Ignite Creation Date:
2025-12-24 @ 7:59 PM
Ignite Modification Date:
2025-12-25 @ 5:33 PM
Study NCT ID:
NCT05184504
Status:
COMPLETED
Last Update Posted:
2025-02-12
First Post:
2021-12-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical-pathological Characterization and Outcomes of Renal Cell Carcinoma in Latin American
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007680', 'term': 'Kidney Neoplasms'}], 'ancestors': [{'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'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': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019370', 'term': 'Observation'}], 'ancestors': [{'id': 'D008722', 'term': 'Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 211}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2024-07-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-11', 'studyFirstSubmitDate': '2021-12-20', 'studyFirstSubmitQcDate': '2022-01-07', 'lastUpdatePostDateStruct': {'date': '2025-02-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Build a real-life renal cell cancer database in Brazil and Latin America', 'timeFrame': '2022'}], 'secondaryOutcomes': [{'measure': 'Sociodemographic characteristics checklist', 'timeFrame': '2022', 'description': 'Describe sociodemographic characteristics: age at diagnosis, race, education, family income, occupation, personal habits, family history, comorbidities, treatment funding (public or private), treatment institution (public, private or philanthropic).'}, {'measure': 'Clinicopathological characteristics of patients with renal cell cancer checklist', 'timeFrame': '2022', 'description': 'date of onset of symptoms, pre-treatment symptoms, histology, clinical and pathological stage, performance status, tests used in staging, date of diagnosis, site of metastases, complications clinics.'}, {'measure': 'Characteristics of systemic treatment checklist', 'timeFrame': '2022', 'description': 'date of biopsy; dates, type and lines of drug treatment.'}, {'measure': 'Time between diagnosis and start of treatment.', 'timeFrame': '2022', 'description': 'Characteristics of systemic treatment checklist'}, {'measure': 'Causes of delay or discontinuation of each treatment checklist', 'timeFrame': '2022', 'description': 'Characteristics of systemic treatment'}, {'measure': 'Progression-free survival in each therapeutic line', 'timeFrame': '2022'}, {'measure': 'Overall survival', 'timeFrame': '2022'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Kidney Neoplasms']}, 'descriptionModule': {'briefSummary': 'Observational study, retrospective and prospective, of an analytical nature. Data will be collected from medical records and/or through contact with physicians and institutions (secondary data collection). Patients included retrospectively or prospectively will be followed during the data collection period for the evaluation of treatments and survival. No intervention is planned in this protocol.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients aged 18 years or older, who have been diagnosed with renal cell carcinoma (new case or recurrence) since January 2015 and during the study recruitment period.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients ≥ 18 years of age;\n* Proven histology of renal cell carcinoma (any subtype);\n* Pathological diagnosis of renal cell carcinoma in January 2015 or later and new cases diagnosed during the period of recruitment of each center;\n* Have the medical record available and suitable for collecting data on patient characteristics, treatment and outcome.\n\nExclusion Criteria:\n\n* Synchronous or other primary tumor within the last 3 years (except thyroid cancer or non melanoma skin).'}, 'identificationModule': {'nctId': 'NCT05184504', 'briefTitle': 'Clinical-pathological Characterization and Outcomes of Renal Cell Carcinoma in Latin American', 'organization': {'class': 'OTHER', 'fullName': 'Latin American Cooperative Oncology Group'}, 'officialTitle': 'Renal Cell Cancer Registry in Latin American Clinical-phatological Characterization and Outcomes of Renal Cell Carcinoma in Latin America', 'orgStudyIdInfo': {'id': 'LACOG 1120'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with pathological diagnosis of renal cell carcinoma', 'description': 'Patients aged 18 years or older, who have been diagnosed with renal cell carcinoma (new case or recurrence) since January 2015 and during the study recruitment period.', 'interventionNames': ['Other: Observational study']}], 'interventions': [{'name': 'Observational study', 'type': 'OTHER', 'description': 'This is an observational study; patients will not be exposed to clinical interventions different from those belonging to the standard of care.', 'armGroupLabels': ['Patients with pathological diagnosis of renal cell carcinoma']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69.020-030', 'city': 'Manaus', 'state': 'Amazonas', 'country': 'Brazil', 'facility': 'CINPAM - Centro Integrado de Pesquisa da Amazônia', 'geoPoint': {'lat': -3.10194, 'lon': -60.025}}, {'zip': '60.135-237', 'city': 'Fortaleza', 'state': 'Ceará', 'country': 'Brazil', 'facility': "Oncocentro Ceará (Rede D'or)", 'geoPoint': {'lat': -3.71722, 'lon': -38.54306}}, {'zip': '29.308-065', 'city': 'Cachoeiro de Itapemirim', 'state': 'Espírito Santo', 'country': 'Brazil', 'facility': 'Hospital Evangélico de Cachoeiro de Itapemirim - Centro de Pesquisas Clínicas em Oncologia (CPCO)', 'geoPoint': {'lat': -20.84889, 'lon': -41.11278}}, {'zip': '44.051-754', 'city': 'Feira de Santana', 'state': 'Estado de Bahia', 'country': 'Brazil', 'facility': 'Santa Casa de Misericórdia de Feira de Santana', 'geoPoint': {'lat': -12.26667, 'lon': -38.96667}}, {'zip': '40.170-110', 'city': 'Salvador', 'state': 'Estado de Bahia', 'country': 'Brazil', 'facility': 'NOB - Núcleo de Oncologia da Bahia (Oncoclínicas)', 'geoPoint': {'lat': -12.97563, 'lon': -38.49096}}, {'zip': '70.390-700', 'city': 'Brasília', 'state': 'Federal District', 'country': 'Brazil', 'facility': 'Onco-Vida Instituto Especializado de Oncologia', 'geoPoint': {'lat': -15.77972, 'lon': -47.92972}}, {'zip': '65.015-460', 'city': 'São Luís', 'state': 'Maranhão', 'country': 'Brazil', 'facility': 'Hospital do Câncer do Maranhão Dr. Tarquínio Lopes Filho', 'geoPoint': {'lat': -2.52972, 'lon': -44.30278}}, {'zip': '79.002-061', 'city': 'Campo Grande', 'state': 'Mato Grosso do Sul', 'country': 'Brazil', 'facility': 'Clinica Prognóstica - Centro de Pesquisa Clínica Onconeo', 'geoPoint': {'lat': -20.44278, 'lon': -54.64639}}, {'zip': '80.510-130', 'city': 'Curitiba', 'state': 'Paraná', 'country': 'Brazil', 'facility': 'ICTR - Instituto do Câncer e Transplante de Curitiba', 'geoPoint': {'lat': -25.42778, 'lon': -49.27306}}, {'zip': '58.013-140', 'city': 'João Pessoa', 'state': 'Paraíba', 'country': 'Brazil', 'facility': 'Hospital Napoleão Laureano', 'geoPoint': {'lat': -7.115, 'lon': -34.86306}}, {'zip': '66.093-032', 'city': 'Belém', 'state': 'Pará', 'country': 'Brazil', 'facility': 'Hospital Porto Dias', 'geoPoint': {'lat': -1.45583, 'lon': -48.50444}}, {'zip': '90.619-900', 'city': 'Porto Alegre', 'state': 'Rio Grande do Sul', 'country': 'Brazil', 'facility': 'CPO - Centro de Pesquisa em Oncologia do Hospital São Lucas da PUCRS', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}, {'zip': '97.015-450', 'city': 'Santa Maria', 'state': 'Rio Grande do Sul', 'country': 'Brazil', 'facility': 'Clínica de Hematologia e Oncologia Viver', 'geoPoint': {'lat': -29.68417, 'lon': -53.80694}}, {'zip': '22.250-905', 'city': 'Rio de Janeiro', 'country': 'Brazil', 'facility': 'CTTB - Centro de Tratamento de Tumores Botafogo (Oncoclínicas)', 'geoPoint': {'lat': -22.90642, 'lon': -43.18223}}, {'zip': '01.236-030', 'city': 'São Paulo', 'country': 'Brazil', 'facility': 'Hemomed Instituto de Oncologia e Hematologia', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'zip': '04.538-135', 'city': 'São Paulo', 'country': 'Brazil', 'facility': 'CPO - Centro Paulista de Oncologia (Oncoclínicas)', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'overallOfficials': [{'name': 'André Poisl Fay', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Latin American Cooperative Oncology Group'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Latin American Cooperative Oncology Group', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ipsen', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}