Ignite Creation Date:
2025-12-24 @ 7:18 PM
Ignite Modification Date:
2026-01-02 @ 1:19 PM
Study NCT ID:
NCT02863003
Status:
COMPLETED
Last Update Posted:
2021-12-27
First Post:
2016-07-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multicenter Database of Patients With Germ Cell Tumor
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}], 'ancestors': [{'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1315}, 'targetDuration': '16 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2020-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-12-23', 'studyFirstSubmitDate': '2016-07-07', 'studyFirstSubmitQcDate': '2016-08-08', 'lastUpdatePostDateStruct': {'date': '2021-12-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-08-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Brazilian multicenter database in order to collect and analyze data from diagnosis and treatment of patients with germ cell tumor', 'timeFrame': 'From 2000 to 2025'}], 'secondaryOutcomes': [{'measure': 'Description of demographic characteristics of testicular germ cell tumor patients in Brazil', 'timeFrame': 'From 2000 to 2025'}, {'measure': 'The clinical and pathological characteristics of testicular germ cell tumor patients in Brazil.', 'timeFrame': 'From 2000 to 2025'}, {'measure': 'Treatment according to staging and relapse of patients diagnosed with testicular germ cell tumor in Brazil', 'timeFrame': 'From 2000 to 2025'}, {'measure': 'Disease free survival of patients diagnosed with germ cell tumor stage 1.', 'timeFrame': 'From 2000 to 2025'}, {'measure': 'Overall survival of patients diagnosed with germ cell tumor stage 1.', 'timeFrame': 'From 2000 to 2025'}, {'measure': 'Disease free survival of patients diagnosed with germ cell tumor stages 2 and 3.', 'timeFrame': 'From 2000 to 2025'}, {'measure': 'Overall survival of patients diagnosed with germ cell tumor stages 2 and 3.', 'timeFrame': 'From 2000 to 2025'}, {'measure': 'International prognostic factors in patients with advanced germ cell tumor (stages 2 and 3) stablished by the International Germ Cell Cancer Collaborative Group in brazilian patients.', 'timeFrame': 'From 2000 to 2025'}, {'measure': 'Treatment outcome in different populations: in patients with brain metastasis, patients with germinative tumor extragonodal, surgery outcome in patients with nonseminomous tumor and ressection of residual lesion after chemotherapy', 'timeFrame': 'From 2000 to 2025'}, {'measure': 'Disease free survival of patients diagnosed with disease relapse after first line chemotherapy', 'timeFrame': 'From 2000 to 2025'}, {'measure': 'Overall survival of patients diagnosed with disease relapse after first line chemotherapy', 'timeFrame': 'From 2000 to 2025'}, {'measure': 'Prognostic model after first line treatment failure with cisplatin, stablished by the International Prognostic Factors Study Group in brazilian patients.', 'timeFrame': 'From 2000 to 2025'}]}, 'conditionsModule': {'conditions': ['Neoplasms, Germ Cell and Embryonal']}, 'descriptionModule': {'briefSummary': 'Retrospective and prospective cohort of patients with germ cell tumor in treatment.', 'detailedDescription': 'The primary objective of this study is to create a multicenter database in order to characterize epidemiologically and clinicopathologically patients with germ cell tumor and evaluate the prognosis and clinical outcomes during cancer treatment.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Men with diagnosis of testicular, retroperitonium or mediastinal primary tumor.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male patients with diagnosis of testicular, retroperitoneum or mediastinal primary tumor.\n* Histological confirmation of germ cell tumor or clinical condition based on the elevation of tumor markers (AFP, HCG e/ou DHL) associated to testicular mass or/and retroperitoneal lymphnode enlargement or/and mediastinal mass.\n* Medical records of the disease and treatment\n\nExclusion Criteria:\n\n* Female patients diagnosed with ovary germ cell tumor\n* Male patients diagnosed with germ cell tumor in other locations.'}, 'identificationModule': {'nctId': 'NCT02863003', 'briefTitle': 'Multicenter Database of Patients With Germ Cell Tumor', 'organization': {'class': 'OTHER', 'fullName': 'Latin American Cooperative Oncology Group'}, 'officialTitle': 'Multicenter Database of Patients With Germ Cell Tumor in Order to Characterize Clinicopathologically and to Evaluate Cancer Treatment Outcomes', 'orgStudyIdInfo': {'id': 'LACOG 0515'}}, 'contactsLocationsModule': {'locations': [{'city': 'Porto Alegre', 'state': 'Rio Grande do Sul', 'country': 'Brazil', 'facility': 'CPO - Pucrs', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}, {'city': 'São Paulo', 'country': 'Brazil', 'facility': 'Hospital Israelita Albert Einstein', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'city': 'São Paulo', 'country': 'Brazil', 'facility': 'Hospital São José', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'city': 'São Paulo', 'country': 'Brazil', 'facility': 'ICESP', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'overallOfficials': [{'name': 'Gustavo Werutsky, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Latin American Cooperative Oncology Group'}, {'name': 'Diogo Bastos, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Instituto do Cancer do Estado de São Paulo'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Latin American Cooperative Oncology Group', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}