Ignite Creation Date:
2025-12-24 @ 3:28 PM
Ignite Modification Date:
2025-12-27 @ 1:51 PM
Study NCT ID:
NCT04569292
Status:
UNKNOWN
Last Update Posted:
2020-09-29
First Post:
2020-09-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
COVID-19 Infection in Cancer Pantients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D009369', 'term': '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2021-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-09-28', 'studyFirstSubmitDate': '2020-09-16', 'studyFirstSubmitQcDate': '2020-09-28', 'lastUpdatePostDateStruct': {'date': '2020-09-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'describe cancer patients with COVID-19 and their clinical course', 'timeFrame': 'Almost 1 year', 'description': 'Describing cancer patients with COVID-19 and their clinical course will help us to identify predictors of the most severe clinical course and also prognostic factors'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COVID-19', 'Oncological patients', 'Cancer', 'Coronavirus infection disease'], 'conditions': ['Covid19']}, 'descriptionModule': {'briefSummary': "It's an obsevational retrospective/prospective study. Analyzing the evolution of COVID 19 infection in cancer patients can provide interesting information in the management of these patients. For this reason, the purpose of this study is to implement a registry to describe and monitor cancer patients affected by COVID 19, the factors that are associated with an unfavorable evolution, to develop a strategy for the risk assessment of these patients and recommendations. relating to their treatment.\n\nParticular attention will be paid to patients suffering from urological tumors because the treatment followed by the patients would seem to expose them to a greater risk when they are infected with coronavirus, furthermore, from the literature it is clear that there may be a connection between sex hormones and ACE2 levels in the plasma. In fact, the estrons up-regulate the concentration of ACE2 in the circulation and this could be the reason why women would seem more protected than men once they contract the coronavirus infection", 'detailedDescription': 'Primary objectives:\n\n* describe cancer patients with COVID-19 and their clinical course;\n* identify predictors of the most severe clinical course;\n* identify prognostic factors; Secondary objectives\n* Monitor patients with urological tumors with particular attention;\n* Dosing parameters of inflammation such as IL-6 and IFNα;\n* Measure the ACE2 levels.\n\nPatients with oncological pathology who contracted COVID 19 infection from January 1, 2020 until the WHO declaration of the end of the pandemic will be studied.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with oncological pathology who contracted COVID 19 infection from January 1, 2020 until the WHO declaration of the end of the pandemic will be studied.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* confirmation of COVID-19 in the laboratory (RT-PCR techniques);\n* suspected cases of COVID-19; clinically diagnosed based on symptoms (fever\\> 37.5 °, decrease in oximeter saturation by at least 5%, cough, diarrhea, otitis, dysgeusia, myalgia, arthralgia, conjunctivitis and rhinorrhea) + close contact a COVID-19 subject positive;\n* asymptomatic cases; diagnosed based on positive swab results but without symptoms even dead patients\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT04569292', 'acronym': 'COICA', 'briefTitle': 'COVID-19 Infection in Cancer Pantients', 'organization': {'class': 'NETWORK', 'fullName': 'Ospedale Andrea Tortora di Pagani'}, 'officialTitle': 'Clinical Course of Cancer Patients Who Contracted COVID 19 Infection: An Observational Study', 'orgStudyIdInfo': {'id': 'COICA_PAG_01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cancer patients', 'description': '* confirmation of COVID-19 in the laboratory (RT-PCR techniques);\n* suspected cases of COVID-19; clinically diagnosed based on symptoms (fever\\> 37.5 °, decrease in oximeter saturation by at least 5%, cough, diarrhea, otitis, dysgeusia, myalgia, arthralgia, conjunctivitis and rhinorrhea) + close contact a COVID-19 subject positive;\n* asymptomatic cases; diagnosed based on positive swab results but without symptoms', 'interventionNames': ['Other: No intervention on patients']}], 'interventions': [{'name': 'No intervention on patients', 'type': 'OTHER', 'description': 'No intervention on patients', 'armGroupLabels': ['Cancer patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '84016', 'city': 'Pagani', 'state': 'Salerno', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Data Manager Oncology Unit', 'role': 'CONTACT', 'email': 'trialclinici.oncopagani@gmail.com', 'phone': '+390819213683'}, {'name': 'Data Manager Oncology Unit', 'role': 'CONTACT', 'email': 'trialclinici.oncopagani@gmail.com', 'phone': '+390819213658'}], 'facility': 'Oncology Unit, Hospital Andrea Tortora', 'geoPoint': {'lat': 40.74199, 'lon': 14.61448}}], 'centralContacts': [{'name': 'Data Manager Oncology Unit', 'role': 'CONTACT', 'email': 'trialclinici.oncopagani@gmail.com', 'phone': '+390819213683'}], 'overallOfficials': [{'name': 'Giuseppe Di Lorenzo', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oncology Unit'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ospedale Andrea Tortora di Pagani', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'SPONSOR'}}}}