Ignite Creation Date:
2025-12-24 @ 9:24 PM
Ignite Modification Date:
2025-12-25 @ 7:10 PM
Study NCT ID:
NCT04578132
Status:
COMPLETED
Last Update Posted:
2025-04-01
First Post:
2020-10-06
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Description of the Population With Genitourinary Tumors and COVID-19
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D011471', 'term': 'Prostatic Neoplasms'}, {'id': 'D007680', 'term': 'Kidney Neoplasms'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'investigacion@mfar.net', 'phone': '+34934344412', 'title': 'A person designated by the Sponsor', 'organization': 'An organization designated by the Sponsor'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '2 year Note: Adverse events were only collected and reported by those patients on active immunotherapy by the time of SARS-CoV-2 infection (n=87)', 'description': 'Adverse events were only collected and reported in the subgroup of patients treated with immunotherapy (n=87) All cause mortality reported in the overall population', 'eventGroups': [{'id': 'EG000', 'title': 'Adverse Events', 'description': 'Adverse events reported by those patients on active immunotherapy by the time of SARS-CoV-2 infection.\n\nThe main scope of this trial was not safety. Therefore, the study did not record adverse events in patients treated with other therapies. The study did not record serious adverse events sistematically.\n\nThis partial information about safety was the only information of adverse events collected during this observational study.', 'otherNumAtRisk': 87, 'deathsNumAtRisk': 408, 'otherNumAffected': 22, 'seriousNumAtRisk': 87, 'deathsNumAffected': 152, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Hepatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numAffected': 7}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Nephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Thyroiditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numAffected': 4}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Hypophysitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Age at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '408', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Genitourinary Cancer Patients That Suffered COVID-19', 'description': 'Patients diagnosed with genitourinary cancer (urothelial, kidney, prostate and germ) that suffered from COVID-19 infection prior to cancer treatment, during treatment, or after treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '70', 'groupId': 'OG000', 'lowerLimit': '17', 'upperLimit': '100'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, at the time of inclusion', 'description': 'Describe the population infected by COVID-19 with genitourinary tumors (urothelial cancer, prostate cancer, testicular cancer and kidney cancer) treated in Spanish hospitals, know the clinical presentation: Spcifically here we reported the Age', 'unitOfMeasure': 'years', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Describe the population infected by COVID-19 with genitourinary tumors (urothelial cancer, prostate cancer, testicular cancer and kidney cancer) treated in Spanish hospitals'}, {'type': 'PRIMARY', 'title': 'Frequency of Complications of COVID-19 Intercurrent Infection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '408', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Genitourinary Cancer Patients That Suffered COVID-19', 'description': 'Patients diagnosed with genitourinary cancer (urothelial, kidney, prostate and germ) that suffered from COVID-19 infection prior to cancer treatment, during treatment, or after treatment.'}], 'classes': [{'categories': [{'title': 'Death secondary to infectioninfection', 'measurements': [{'value': '73', 'groupId': 'OG000'}]}, {'title': 'ICU admission due to need of symptom control', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}, {'title': 'Hospital admission due to need of symptom control', 'measurements': [{'value': '136', 'groupId': 'OG000'}]}, {'title': 'Need for mechanical ventilation', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'No complications. Common infection at home', 'measurements': [{'value': '191', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Through study completion, average 1 year', 'description': 'Percentage of patients with complications associated to COVID-19 infection (classified by type and severity)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Describe the population infected by COVID-19 with genitourinary tumors (urothelial cancer, prostate cancer, testicular cancer and kidney cancer) treated in Spanish hospitals'}, {'type': 'PRIMARY', 'title': 'Frequency of Complications of COVID-19 Infection (Pneumonia) Stratified by Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '408', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Genitourinary Cancer Patients That Suffered COVID-19', 'description': 'Patients diagnosed with genitourinary cancer (urothelial, kidney, prostate and germ) that suffered from COVID-19 infection prior to cancer treatment, during treatment, or after treatment.'}], 'classes': [{'categories': [{'title': 'Immunotherapy treatment/no Pneumonia', 'measurements': [{'value': '51', 'groupId': 'OG000'}]}, {'title': 'Immunotherapy treatment/ Pneumonia', 'measurements': [{'value': '36', 'groupId': 'OG000'}]}, {'title': 'No Immunotherapy treatment/no Pneumonia', 'measurements': [{'value': '181', 'groupId': 'OG000'}]}, {'title': 'No Immunotherapy treatment/Pneumonia', 'measurements': [{'value': '140', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Through study completion, average 1 year', 'description': 'To assess the possible relationship of the different oncological treatments administered to these patients with the clinical evolution of the COVID-19 infection. Complications will be classified by type and severity in groups of patients stratified by the oncological treatment received.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Frequency of Complications of COVID-19 Infection in Patients With Genitourinary Cancer Stratified by Anti-androgenic Oncological Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '408', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Genitourinary Cancer Patients That Suffered COVID-19', 'description': 'Patients diagnosed with genitourinary cancer (urothelial, kidney, prostate and germ) that suffered from COVID-19 infection prior to cancer treatment, during treatment, or after treatment.'}], 'classes': [{'categories': [{'title': 'Corticosteroid treatment/ no Pneumonia', 'measurements': [{'value': '59', 'groupId': 'OG000'}]}, {'title': 'Corticosteroid treatment/ si Pneumonia', 'measurements': [{'value': '55', 'groupId': 'OG000'}]}, {'title': 'No Corticosteroid treatment/ no Pneumonia', 'measurements': [{'value': '173', 'groupId': 'OG000'}]}, {'title': 'No Corticosteroid treatment/ si Pneumonia', 'measurements': [{'value': '120', 'groupId': 'OG000'}]}, {'title': 'UK', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Through study completion, average 1 year', 'description': 'To evaluate in patients with Genitourinary Cancer the impact of androgen deprivation therapy (ADT) and new antiandrogenic agents (NAH) with or without corticosteroids on the infection COVID-19 as mean of frequency in complications of COVID-19 infection classified by type and severity', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Frequency of Complications of COVID-19 Infection Stratified by Treatment (Immunotherapy vs no Immunotherapy)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '408', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Genitourinary Cancer Patients That Suffered COVID-19', 'description': 'Patients diagnosed with genitourinary cancer (urothelial, kidney, prostate and germ) that suffered from COVID-19 infection prior to cancer treatment, during treatment, or after treatment.'}], 'classes': [{'categories': [{'title': 'Immunotherapy treatment /no complications', 'measurements': [{'value': '45', 'groupId': 'OG000'}]}, {'title': 'Immunotherapy treatment /admissions', 'measurements': [{'value': '31', 'groupId': 'OG000'}]}, {'title': 'Immunotherapy treatment /Death secondary to infection', 'measurements': [{'value': '11', 'groupId': 'OG000'}]}, {'title': 'No Immunotherapy treatment /no complications', 'measurements': [{'value': '146', 'groupId': 'OG000'}]}, {'title': 'No Immunotherapy treatment /admissions', 'measurements': [{'value': '113', 'groupId': 'OG000'}]}, {'title': 'No Immunotherapy treatment /Death secondary to infection', 'measurements': [{'value': '62', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Through study completion, average 1 year', 'description': 'To assess the possible relationship of the different oncological treatments administered to these patients with the clinical evolution of the COVID-19 infection. Complications will be classified by type and severity in groups of patients stratified by the oncological treatment received.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Frequency of Adverse Events Related to Immunotherapy Targeted to Cancer (Classified by Type and Severity)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients Diagnosed With Genitourinary Cancer Hat Suffered COVID-19 Treatment With Immunotherapy', 'description': 'Patients diagnosed with genitourinary cancer (urothelial, kidney, prostate and germ) that suffered from COVID-19 infection prior to cancer treatment, during treatment, or after treatment with immunotherapy'}], 'classes': [{'title': 'Arthritis G1', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Arthritis G3', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Colitis G1', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Colitis G2', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Colitis G3', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Hepatitis G2', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Hepatitis G3', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Hepatitis G4', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Hypophysitis G2', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Nephritis G1', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Nephritis G2', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Nephritis G3', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Nephritis G4', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Pneumonitis G2', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Thyroiditis G1', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Thyroiditis G2', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Through study completion, average 1 year. Measured at 3 scenarios (during treatment, after treatment and therapies indicated after infection has passed)', 'description': 'To specifically assess the impact of COVID-19 infection on the toxicity of immunotherapy treatment (mainly pneumonitis) and the impact of immunotherapy on the evolution of the infectious picture in patients with tumors of genitourinary origin. three different scenarios: during treatment, after treatment and in patients who receive treatment after the infection has passed.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'COVID-19 Mortality Rate in Patients With Genitourinary Cancer', 'denoms': [{'units': 'Participants', 'counts': [{'value': '408', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Genitourinary Cancer Patients That Suffered COVID-19', 'description': 'Patients diagnosed with genitourinary cancer (urothelial, kidney, prostate and germ) that suffered from COVID-19 infection prior to cancer treatment, during treatment, or after treatment.'}], 'classes': [{'categories': [{'title': 'Alive', 'measurements': [{'value': '137', 'groupId': 'OG000'}]}, {'title': 'Dead', 'measurements': [{'value': '80', 'groupId': 'OG000'}]}, {'title': 'NA', 'measurements': [{'value': '191', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Through study completion, average 1 year', 'description': 'To assess the mortality associated with COVID-19 infection in the population with genitourinary tumors. Percentage of patients alive / dead at discharge.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'COVID-19 Complication Rate in Patients With Genitourinary Cancer', 'denoms': [{'units': 'Participants', 'counts': [{'value': '408', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Genitourinary Cancer Patients That Suffered COVID-19', 'description': 'Patients diagnosed with genitourinary cancer (urothelial, kidney, prostate and germ) that suffered from COVID-19 infection prior to cancer treatment, during treatment, or after treatment.'}], 'classes': [{'categories': [{'title': 'Death secondary to infection', 'measurements': [{'value': '73', 'groupId': 'OG000'}]}, {'title': 'ICU admission due to need of symptom control', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}, {'title': 'Hospital admission due to need of symptom control', 'measurements': [{'value': '136', 'groupId': 'OG000'}]}, {'title': 'Need for mechanical ventilation', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'No complications. Common infection at home', 'measurements': [{'value': '191', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Through study completion, average 1 year', 'description': 'Evaluate the rate (percentage) of complications that have required hospital admission and / or ICU treatment. Complications will be classified by type and severity and represented as percentage of patients presenting them.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Asymptomatic Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '408', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Genitourinary Cancer Patients That Suffered COVID-19', 'description': 'Patients diagnosed with genitourinary cancer (urothelial, kidney, prostate and germ) that suffered from COVID-19 infection prior to cancer treatment, during treatment, or after treatment.'}], 'classes': [{'categories': [{'title': 'symptomatic', 'measurements': [{'value': '308', 'groupId': 'OG000'}]}, {'title': 'Asymptomatic', 'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Through study completion, average 1 year', 'description': 'Describe the frequency of asymptomatic or minimally symptomatic COVID-19 infections.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Asymptomatic Rate in Renal Cancer', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Renal Cancer Patients That Suffered COVID-19', 'description': 'Patients diagnosed with renal cancer that suffered from COVID-19 infection prior to cancer treatment, during treatment, or after treatment.'}], 'classes': [{'categories': [{'title': 'Symptomatic', 'measurements': [{'value': '63', 'groupId': 'OG000'}]}, {'title': 'Asymptomatic', 'measurements': [{'value': '27', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Through study completion, average 1 year', 'description': 'Describe the frequency of asymptomatic or minimally symptomatic COVID-19 infections.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Asymptomatic Rate in Urothelial Cancer', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Urothelial Cancer Patients That Suffered COVID-19', 'description': 'Patients diagnosed with urothelial cancer that suffered from COVID-19 infection prior to cancer treatment, during treatment, or after treatment.'}], 'classes': [{'categories': [{'title': 'Asymptomatic', 'measurements': [{'value': '32', 'groupId': 'OG000'}]}, {'title': 'Symptomatic', 'measurements': [{'value': '96', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Through study completion, average 1 year', 'description': 'Describe the frequency of asymptomatic or minimally symptomatic COVID-19 infections.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Asymptomatic Rate in Prostate Cancer', 'denoms': [{'units': 'Participants', 'counts': [{'value': '166', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Prostate Cancer Patients That Suffered COVID-19', 'description': 'Patients diagnosed with prostate cancer that suffered from COVID-19 infection prior to cancer treatment, during treatment, or after treatment.'}], 'classes': [{'categories': [{'title': 'Asymptomatic', 'measurements': [{'value': '33', 'groupId': 'OG000'}]}, {'title': 'Symptomatic', 'measurements': [{'value': '133', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Through study completion, average 1 year', 'description': 'Describe the frequency of asymptomatic or minimally symptomatic COVID-19 infections', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Asymptomatic Rate in Testicular Cancer', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Testicular Cancer Patients That Suffered COVID-19', 'description': 'Patients diagnosed with testicular cancer that suffered from COVID-19 infection prior to cancer treatment, during treatment, or after treatment.'}], 'classes': [{'categories': [{'title': 'asymptomatic', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}, {'title': 'symptomatic', 'measurements': [{'value': '15', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Through study completion, average 1 year', 'description': 'Describe the frequency of asymptomatic or minimally symptomatic COVID-19 infections', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Frequency of Delays/Modifications on Cancer Treatment Schedule', 'denoms': [{'units': 'Participants', 'counts': [{'value': '326', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients With Genitourinary Tumor Presenting Covid-19 Infection With Prospective Part', 'description': 'Patients with prospective part'}], 'classes': [{'categories': [{'title': 'Start Treatment after COVID-19', 'measurements': [{'value': '20', 'groupId': 'OG000'}]}, {'title': 'Restart Treatment after COVID-19', 'measurements': [{'value': '146', 'groupId': 'OG000'}]}, {'title': 'With treatment after COVID-19 without specifying start/restart', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}, {'title': 'Without oncology treatment after COVID-19 (reported)', 'measurements': [{'value': '154', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Through study completion, average 1 year', 'description': 'delays / modifications in cancer follow-up or treatment regimens.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients with genitourinary tumor presenting Covid-19 infection with prospective part who start/restart treatment'}, {'type': 'SECONDARY', 'title': 'Frequency of Delays/Modifications on Cancer Treatment Schedule', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients With Genitourinary Tumor Presenting Covid-19 Infection With Prospective Part', 'description': 'Patients with genitourinary tumor presenting Covid-19 infection with treatment modifications in cancer follow-up or treatment regimens.'}], 'classes': [{'categories': [{'title': 'Dose', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Change in administration schedule', 'measurements': [{'value': '15', 'groupId': 'OG000'}]}, {'title': 'Temporary suspension of treatment', 'measurements': [{'value': '22', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Through study completion, average 1 year', 'description': 'delays / modifications in cancer follow-up or treatment regimens.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients with genitourinary tumor presenting Covid-19 infection with prospective part witn treatment modifications'}, {'type': 'SECONDARY', 'title': 'Frequency of Delays/Modifications on Cancer Treatment Schedule', 'denoms': [{'units': 'Participants', 'counts': [{'value': '326', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients With Genitourinary Tumor Presenting Covid-19 Infection With Prospective Part', 'description': 'Patients with prospective part'}], 'classes': [{'categories': [{'title': 'Yes Treatment modification (prospective visit)', 'measurements': [{'value': '38', 'groupId': 'OG000'}]}, {'title': 'No Treatment modification (prospective visit)', 'measurements': [{'value': '108', 'groupId': 'OG000'}]}, {'title': 'New treatment o no treatment start date', 'measurements': [{'value': '24', 'groupId': 'OG000'}]}, {'title': 'NA/UK', 'measurements': [{'value': '156', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Through study completion, average 1 year', 'description': 'delays / modifications in cancer follow-up or treatment regimens.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients with genitourinary tumor presenting Covid-19 infection with prospective part'}, {'type': 'SECONDARY', 'title': 'Progression Free Survival in Patients With Genitourinary Tumors That Suffered COVID-19, Patients With a First Line Treatment Ongoing at the Moment of COVID Infection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Genitourinary Cancer Patients With a First Line Treatment Ongoing at the Moment of COVID Infection.', 'description': 'Patients diagnosed with genitourinary cancer (urothelial, kidney, prostate and germ) that suffered from COVID-19 infection with a first line treatment ongoing at the moment of COVID infection were analyzed.'}], 'classes': [{'title': 'Renal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '93.26', 'groupId': 'OG000', 'lowerLimit': '45.62', 'upperLimit': '140.91'}]}]}, {'title': 'Urothelial', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '80.13', 'groupId': 'OG000', 'lowerLimit': '28.38', 'upperLimit': '131.88'}]}]}, {'title': 'Prostate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '121.94', 'groupId': 'OG000', 'lowerLimit': '96.68', 'upperLimit': '147.2'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From start of treatment until progression or death, up to 130 months', 'description': 'It is expected to obtain data on time to progression and overall survival of cancer patients, which can be compared with the reference values for each type of tumor pathology.\n\nPROGRESSION FREE SURVIVAL (FIRST LINE IN METASTATIC OR ADVANCED SETTING) The date of treatment start (treatment ongoing at the moment of COVID infection) is taken as the start date of follow-up. Only patients with a first line treatment ongoing at the moment of COVID infection were analyzed.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients with genitourinary tumors that suffered COVID-19. Only patients with a first line treatment ongoing at the moment of COVID infection were analyzed.'}, {'type': 'SECONDARY', 'title': 'Overall Survival in Patients With Genitourinary Tumors That Suffered COVID-19', 'denoms': [{'units': 'Participants', 'counts': [{'value': '405', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients With Genitourinary Tumor Presenting Covid-19 Infection With Prospective Part', 'description': 'Patients with prospective part'}], 'classes': [{'title': 'Renal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '18.36', 'groupId': 'OG000', 'lowerLimit': '14.51', 'upperLimit': '22.22'}]}]}, {'title': 'Urothelial', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7.03', 'groupId': 'OG000', 'lowerLimit': '4.91', 'upperLimit': '9.14'}]}]}, {'title': 'Prostate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '166', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '11.49', 'groupId': 'OG000', 'lowerLimit': '9.85', 'upperLimit': '13.13'}]}]}, {'title': 'Testicular', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '24.37', 'groupId': 'OG000', 'lowerLimit': '19.97', 'upperLimit': '28.76'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From start of treatment until progression or death, up to 130 months', 'description': 'It is expected to obtain data on time to progression and overall survival of cancer patients, which can be compared with the reference values for each type of tumor pathology.\n\nFor the calculation of overall survival, it is taken from the date of cancer diagnosis to the date of death (at any time, not only in a prospective part).', 'unitOfMeasure': 'years', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients with genitourinary tumor presenting Covid-19 infection with prospective part'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Genitourinary Cancer Patients That Suffered COVID-19', 'description': 'Patients diagnosed with genitourinary cancer (urothelial, kidney, prostate and germ) that suffered from COVID-19 infection prior to cancer treatment, during treatment, or after treatment.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '410'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '410'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '408', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Genitourinary Cancer Patients That Suffered COVID-19', 'description': 'Patients diagnosed with genitourinary cancer (urothelial, kidney, prostate and germ) that suffered from COVID-19 infection prior to cancer treatment, during treatment, or after treatment.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '70', 'groupId': 'BG000', 'lowerLimit': '17', 'upperLimit': '100'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '51', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '357', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '408', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Smoking status', 'classes': [{'categories': [{'title': 'Never', 'measurements': [{'value': '136', 'groupId': 'BG000'}]}, {'title': 'Ever', 'measurements': [{'value': '231', 'groupId': 'BG000'}]}, {'title': 'UK', 'measurements': [{'value': '41', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Comorbities', 'classes': [{'title': 'Hypertension', 'categories': [{'measurements': [{'value': '224', 'groupId': 'BG000'}]}]}, {'title': 'Diabetes', 'categories': [{'measurements': [{'value': '92', 'groupId': 'BG000'}]}]}, {'title': 'Cardiopathy', 'categories': [{'measurements': [{'value': '79', 'groupId': 'BG000'}]}]}, {'title': 'COPD / Asma', 'categories': [{'measurements': [{'value': '57', 'groupId': 'BG000'}]}]}, {'title': 'Hepatopathy', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}]}]}, {'title': 'Nephropathy', 'categories': [{'measurements': [{'value': '53', 'groupId': 'BG000'}]}]}, {'title': 'None', 'categories': [{'measurements': [{'value': '121', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Cancer type', 'classes': [{'categories': [{'title': 'Prostate', 'measurements': [{'value': '166', 'groupId': 'BG000'}]}, {'title': 'Urothelial', 'measurements': [{'value': '128', 'groupId': 'BG000'}]}, {'title': 'Kidney', 'measurements': [{'value': '90', 'groupId': 'BG000'}]}, {'title': 'Testicular', 'measurements': [{'value': '23', 'groupId': 'BG000'}]}, {'title': 'Penile', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Clinical cancer stage at cancer diagnosis;', 'classes': [{'categories': [{'title': '0', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'I', 'measurements': [{'value': '54', 'groupId': 'BG000'}]}, {'title': 'II', 'measurements': [{'value': '64', 'groupId': 'BG000'}]}, {'title': 'III', 'measurements': [{'value': '90', 'groupId': 'BG000'}]}, {'title': 'IV', 'measurements': [{'value': '166', 'groupId': 'BG000'}]}, {'title': 'UK', 'measurements': [{'value': '32', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Cancer staging measures the extent of spread of the disease. This scale is established by the American Joint Committee in Cancer (AJCC). The categories range from localized / regional tumours (Stage I-II) to locally advanced (Stage III) or metastatic (Stage IV)', 'unitOfMeasure': 'Participants'}, {'title': 'Time from cancer diagnosis to SARS-CoV-2 infection', 'classes': [{'categories': [{'measurements': [{'value': '32', 'groupId': 'BG000', 'lowerLimit': '27', 'upperLimit': '38'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'months', 'dispersionType': 'FULL_RANGE'}, {'title': 'Clinical cancer stage at SARS-CoV-2 infection', 'classes': [{'categories': [{'title': 'o', 'measurements': [{'value': '24', 'groupId': 'BG000'}]}, {'title': 'I', 'measurements': [{'value': '19', 'groupId': 'BG000'}]}, {'title': 'II', 'measurements': [{'value': '22', 'groupId': 'BG000'}]}, {'title': 'III', 'measurements': [{'value': '29', 'groupId': 'BG000'}]}, {'title': 'IV', 'measurements': [{'value': '291', 'groupId': 'BG000'}]}, {'title': 'UK', 'measurements': [{'value': '23', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Cancer staging measures the extent of spread of the disease. This scale is established by the American Joint Committee in Cancer (AJCC). The categories range from localized / regional tumours (Stage I-II) to locally advanced (Stage III) or metastatic (Stage IV)', 'unitOfMeasure': 'Participants'}, {'title': 'Histopathological grade at SARS-CoV-2 infection', 'classes': [{'categories': [{'title': 'Well differentiated', 'measurements': [{'value': '31', 'groupId': 'BG000'}]}, {'title': 'Moderately differentiated', 'measurements': [{'value': '61', 'groupId': 'BG000'}]}, {'title': 'Poorly differentiated', 'measurements': [{'value': '136', 'groupId': 'BG000'}]}, {'title': 'UK', 'measurements': [{'value': '180', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Anticancer treatment status at SARS-CoV-2 infection', 'classes': [{'categories': [{'title': 'Active', 'measurements': [{'value': '238', 'groupId': 'BG000'}]}, {'title': 'Follow-up', 'measurements': [{'value': '170', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Anticancer treatment type at SARS-CoV-2 infection', 'classes': [{'title': 'Neo-adjuvant', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}, {'title': 'Adjuvant', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}, {'title': 'Metastatic / palliative', 'categories': [{'measurements': [{'value': '219', 'groupId': 'BG000'}]}]}, {'title': 'UK', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-08-10', 'size': 255006, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-03-28T11:59', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'ECOLOGIC_OR_COMMUNITY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 410}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-12-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2022-11-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-31', 'studyFirstSubmitDate': '2020-10-06', 'resultsFirstSubmitDate': '2023-10-10', 'studyFirstSubmitQcDate': '2020-10-06', 'lastUpdatePostDateStruct': {'date': '2025-04-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-03-31', 'studyFirstPostDateStruct': {'date': '2020-10-08', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-04-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Age at Baseline', 'timeFrame': 'Baseline, at the time of inclusion', 'description': 'Describe the population infected by COVID-19 with genitourinary tumors (urothelial cancer, prostate cancer, testicular cancer and kidney cancer) treated in Spanish hospitals, know the clinical presentation: Spcifically here we reported the Age'}, {'measure': 'Frequency of Complications of COVID-19 Intercurrent Infection', 'timeFrame': 'Through study completion, average 1 year', 'description': 'Percentage of patients with complications associated to COVID-19 infection (classified by type and severity)'}, {'measure': 'Frequency of Complications of COVID-19 Infection (Pneumonia) Stratified by Treatment', 'timeFrame': 'Through study completion, average 1 year', 'description': 'To assess the possible relationship of the different oncological treatments administered to these patients with the clinical evolution of the COVID-19 infection. Complications will be classified by type and severity in groups of patients stratified by the oncological treatment received.'}, {'measure': 'Frequency of Complications of COVID-19 Infection in Patients With Genitourinary Cancer Stratified by Anti-androgenic Oncological Treatment', 'timeFrame': 'Through study completion, average 1 year', 'description': 'To evaluate in patients with Genitourinary Cancer the impact of androgen deprivation therapy (ADT) and new antiandrogenic agents (NAH) with or without corticosteroids on the infection COVID-19 as mean of frequency in complications of COVID-19 infection classified by type and severity'}, {'measure': 'Frequency of Complications of COVID-19 Infection Stratified by Treatment (Immunotherapy vs no Immunotherapy)', 'timeFrame': 'Through study completion, average 1 year', 'description': 'To assess the possible relationship of the different oncological treatments administered to these patients with the clinical evolution of the COVID-19 infection. Complications will be classified by type and severity in groups of patients stratified by the oncological treatment received.'}, {'measure': 'Frequency of Adverse Events Related to Immunotherapy Targeted to Cancer (Classified by Type and Severity)', 'timeFrame': 'Through study completion, average 1 year. Measured at 3 scenarios (during treatment, after treatment and therapies indicated after infection has passed)', 'description': 'To specifically assess the impact of COVID-19 infection on the toxicity of immunotherapy treatment (mainly pneumonitis) and the impact of immunotherapy on the evolution of the infectious picture in patients with tumors of genitourinary origin. three different scenarios: during treatment, after treatment and in patients who receive treatment after the infection has passed.'}], 'secondaryOutcomes': [{'measure': 'COVID-19 Mortality Rate in Patients With Genitourinary Cancer', 'timeFrame': 'Through study completion, average 1 year', 'description': 'To assess the mortality associated with COVID-19 infection in the population with genitourinary tumors. Percentage of patients alive / dead at discharge.'}, {'measure': 'COVID-19 Complication Rate in Patients With Genitourinary Cancer', 'timeFrame': 'Through study completion, average 1 year', 'description': 'Evaluate the rate (percentage) of complications that have required hospital admission and / or ICU treatment. Complications will be classified by type and severity and represented as percentage of patients presenting them.'}, {'measure': 'Asymptomatic Rate', 'timeFrame': 'Through study completion, average 1 year', 'description': 'Describe the frequency of asymptomatic or minimally symptomatic COVID-19 infections.'}, {'measure': 'Asymptomatic Rate in Renal Cancer', 'timeFrame': 'Through study completion, average 1 year', 'description': 'Describe the frequency of asymptomatic or minimally symptomatic COVID-19 infections.'}, {'measure': 'Asymptomatic Rate in Urothelial Cancer', 'timeFrame': 'Through study completion, average 1 year', 'description': 'Describe the frequency of asymptomatic or minimally symptomatic COVID-19 infections.'}, {'measure': 'Asymptomatic Rate in Prostate Cancer', 'timeFrame': 'Through study completion, average 1 year', 'description': 'Describe the frequency of asymptomatic or minimally symptomatic COVID-19 infections'}, {'measure': 'Asymptomatic Rate in Testicular Cancer', 'timeFrame': 'Through study completion, average 1 year', 'description': 'Describe the frequency of asymptomatic or minimally symptomatic COVID-19 infections'}, {'measure': 'Frequency of Delays/Modifications on Cancer Treatment Schedule', 'timeFrame': 'Through study completion, average 1 year', 'description': 'delays / modifications in cancer follow-up or treatment regimens.'}, {'measure': 'Progression Free Survival in Patients With Genitourinary Tumors That Suffered COVID-19, Patients With a First Line Treatment Ongoing at the Moment of COVID Infection', 'timeFrame': 'From start of treatment until progression or death, up to 130 months', 'description': 'It is expected to obtain data on time to progression and overall survival of cancer patients, which can be compared with the reference values for each type of tumor pathology.\n\nPROGRESSION FREE SURVIVAL (FIRST LINE IN METASTATIC OR ADVANCED SETTING) The date of treatment start (treatment ongoing at the moment of COVID infection) is taken as the start date of follow-up. Only patients with a first line treatment ongoing at the moment of COVID infection were analyzed.'}, {'measure': 'Overall Survival in Patients With Genitourinary Tumors That Suffered COVID-19', 'timeFrame': 'From start of treatment until progression or death, up to 130 months', 'description': 'It is expected to obtain data on time to progression and overall survival of cancer patients, which can be compared with the reference values for each type of tumor pathology.\n\nFor the calculation of overall survival, it is taken from the date of cancer diagnosis to the date of death (at any time, not only in a prospective part).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Urothelial cancer', 'prostate cancer', 'Germ line cancer', 'Kidney cancer', 'COVID-19'], 'conditions': ['Covid19', 'Genito Urinary Cancer']}, 'descriptionModule': {'briefSummary': 'The identification of patients with genitourinary tumors who suffer from the infection by the Serious Acute Respiratory Syndrome Corona-Virus 2 (SARS-CoV-2) virus can represent multiple benefits both for themselves and for health professionals and the health system itself. We would be able to know more precisely the clinical evolution of these type of patient, to know their prognosis and being capable to select the most appropriate treatment modality for future pandemics.\n\nSOGUG-COVID is an observational prospective-retrospective trial purely epidemiological, that aims to describe the population with genitourinary tumors (urothelial cancer, prostate cancer, testicular cancer and kidney cancer) infected by COrona VIrus Disease 19 (COVID-19) treated in Spanish hospitals, learn about the clinical presentation, therapeutic evolution and prognosis of said intercurrent infectious process, as well as its possible relationship with different clinical and therapeutic factors.', 'detailedDescription': "The study will be carried out in Spanish hospitals, with principal investigators belonging to the medical oncology services of the SOGUG group (Spanish Group of Genitourinary Oncology), who will act as promoter. Once the patients have been selected, the variables of interest will be collected and studied. The main variables to record will be:\n\n1. Patient characteristics\n2. Hospital center where the patient is recruited\n3. Pathological history:\n\n Concomitant pathology Usual drug treatment\n4. Tumor pathology:\n\n Tumor type, histology, and stage (initial and at diagnosis of infection) Cancer diagnosis date Active cancer treatment or follow-up Participation in clinical trial Type of treatment most recently received for the infection (Surgery; Radiotherapy; Chemotherapy, Immunotherapy ...) Treatment lines, initiation and last dose received of the most recent most recent cancer treatment\n5. COVID-19 infection:\n\n Confirmation date of COVID-19 infection PCR (Polymerase Chain Reaction) diagnostic test Immunoglobulin G (IgG) or Immunoglobulin M (IgM) serological diagnostic test Present symptoms, analytical alterations, thrombosis associated with COVID-19 infection, complications of infection Date of onset and disappearance of symptoms Days of fever and cough Radiological examination at the time of greatest severity Treatments received for COVID-19 Status upon discharge Date of discharge / exitus Negative presence of virus by PCR and PCR date\n6. For patients who are receiving or have received immunotherapy treatments, additional information will be collected:\n\n Immunotherapy treatment line and type Start / end date and last dose previous infection of the treatment with immunotherapy Adverse effects\n7. Prospective follow-up data (6 months from patient inclusion):\n\nDate of start or restart of cancer treatment after infection Change / suspension of cancer treatment after COVID-19 Date of surgery in neoadjuvant patients Recurrence of COVID-19 Best response obtained Date of progression to cancer treatment Current status and date of last contact The study will use the data obtained from the patient's medical history, with no plans to use other sources.\n\nThe assignment of a patient to a specific therapeutic strategy has already been decided in advance by the usual clinical practice of medicine; The decision to prescribe a specific treatment is clearly dissociated from the decision to include a patient in the study. No intervention will be applied to patients, whether diagnostic or follow-up, that is not the usual clinical practice. Epidemiological methods will be used to analyze the collected data."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients diagnosed with genitourinary cancer (urothelial, kidney, prostate and germ) that suffered COVID-19 infection prior to cancer treatment, during treatment, or after treatment.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients ≥18 years old.\n* Diagnosed with genitourinary cancer (urothelial, kidney, prostate and germ).\n* COVID-19 infection prior to cancer treatment, during treatment, or after treatment.\n* The COVID-19 infection must be confirmed by PCR or serology, regardless of whether or not the patient requires hospitalization for the infection, additionally, a clinical and / or radiological determination must be available in those patients who present symptoms.\n\nExclusion Criteria:\n\n* Not applicable'}, 'identificationModule': {'nctId': 'NCT04578132', 'acronym': 'SOGUGCOVID', 'briefTitle': 'Description of the Population With Genitourinary Tumors and COVID-19', 'organization': {'class': 'OTHER', 'fullName': 'Spanish Oncology Genito-Urinary Group'}, 'officialTitle': 'Observational Retrospective-prospective Study in Patients With Genitourinary Tumors Presenting COVID-19 Infection (SOGUG-COVID-19)', 'orgStudyIdInfo': {'id': 'SOG-INM-2020-04'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Genitourinary cancer patients that suffered COVID-19', 'description': 'Patients diagnosed with genitourinary cancer (urothelial, kidney, prostate and germ) that suffered from COVID-19 infection prior to cancer treatment, during treatment, or after treatment.'}]}, 'contactsLocationsModule': {'locations': [{'city': "L'Hospitalet de Llobregat", 'state': 'Barcelona', 'country': 'Spain', 'facility': "Institut Català d'Oncologia L'Hospitalet", 'geoPoint': {'lat': 41.35967, 'lon': 2.10028}}, {'city': 'Manresa', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Althaia', 'geoPoint': {'lat': 41.72815, 'lon': 1.82399}}, {'city': 'Sabadell', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Universitari Parc Taulí', 'geoPoint': {'lat': 41.54329, 'lon': 2.10942}}, {'city': 'Majadahonda', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario Puerta de Hierro-Majadahonda', 'geoPoint': {'lat': 40.47353, 'lon': -3.87182}}, {'city': 'Badajoz', 'country': 'Spain', 'facility': 'Hospital Universitario de Badajoz', 'geoPoint': {'lat': 38.87789, 'lon': -6.97061}}, {'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital del Mar', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Santa Creu i Sant Pau', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Universitario Vall d Hebron', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Burgos', 'country': 'Spain', 'facility': 'Hospital Universitario de Burgos', 'geoPoint': {'lat': 42.34106, 'lon': -3.70184}}, {'city': 'Ciudad Real', 'country': 'Spain', 'facility': 'Hospital de Ciudad Real', 'geoPoint': {'lat': 38.98626, 'lon': -3.92907}}, {'city': 'Córdoba', 'country': 'Spain', 'facility': 'Hospital Universitario Reina Sofía', 'geoPoint': {'lat': 37.89155, 'lon': -4.77275}}, {'city': 'Girona', 'country': 'Spain', 'facility': 'Instituto Catalán de Oncología- Girona', 'geoPoint': {'lat': 41.98311, 'lon': 2.82493}}, {'city': 'Lugo', 'country': 'Spain', 'facility': 'Hospital Universitario Lucus Augusti', 'geoPoint': {'lat': 43.00992, 'lon': -7.55602}}, {'city': 'Madrid', 'country': 'Spain', 'facility': 'Fundación Jiménez Díaz', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital 12 de Octubre', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Clínico San Carlos de Madrid', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Infanta Leonor,', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario Gregorio Marañón', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario HM Sanchinarro', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario La Paz', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario La Princesa', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario Quironsalud', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario Ramón y Cajal', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Ourense', 'country': 'Spain', 'facility': 'Complejo Hospitalario Universitario Ourense', 'geoPoint': {'lat': 42.33669, 'lon': -7.86407}}, {'city': 'Pamplona', 'country': 'Spain', 'facility': 'Clinica Universidad de Navarra', 'geoPoint': {'lat': 42.81687, 'lon': -1.64323}}, {'city': 'Seville', 'country': 'Spain', 'facility': 'Hospital Universitario Virgen Macarena', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'city': 'Talavera de la Reina', 'country': 'Spain', 'facility': 'Hospital Nuestra Señora del Prado', 'geoPoint': {'lat': 39.96348, 'lon': -4.83076}}, {'city': 'Toledo', 'country': 'Spain', 'facility': 'Hospital Virgen de la Salud', 'geoPoint': {'lat': 39.8581, 'lon': -4.02263}}, {'city': 'Valencia', 'country': 'Spain', 'facility': 'Hospital Universitario Dr. Peset', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'city': 'Valencia', 'country': 'Spain', 'facility': 'Instituto Valenciano de Oncología', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'city': 'Vitoria-Gasteiz', 'country': 'Spain', 'facility': 'Hospital Txagorritxu', 'geoPoint': {'lat': 42.84998, 'lon': -2.67268}}, {'city': 'Zaragoza', 'country': 'Spain', 'facility': 'Hospital Miguel Servet', 'geoPoint': {'lat': 41.65606, 'lon': -0.87734}}], 'overallOfficials': [{'name': 'Miguel Ángel Climent, M.D., Ph.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Instituto Valenciano de Oncología'}, {'name': 'Javier Puente, M.D., Ph.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Hospital Clínico San Carlos de Madrid'}, {'name': 'Aránzazu González del Alba, M.D., Ph.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Hospital Universitario Puerta de Hierro-Majadahonda'}, {'name': 'Sergio Vázquez Estevez, M.D., Ph.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Hospital Universitario Lucus Augusti'}, {'name': 'Natalia Vidal, M.D., Ph.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Hospital Clínico San Carlos de Madrid'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Spanish Oncology Genito-Urinary Group', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}