Neoplasms, Germ Cell and Embryonal Clinical Trial
Official title:
Multicenter Database of Patients With Germ Cell Tumor in Order to Characterize Clinicopathologically and to Evaluate Cancer Treatment Outcomes
| NCT number | NCT02863003 |
| Other study ID # | LACOG 0515 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | September 2016 |
| Est. completion date | December 2020 |
| Verified date | August 2021 |
| Source | Latin American Cooperative Oncology Group |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational [Patient Registry] |
Retrospective and prospective cohort of patients with germ cell tumor in treatment.
| Status | Completed |
| Enrollment | 1315 |
| Est. completion date | December 2020 |
| Est. primary completion date | December 2019 |
| Accepts healthy volunteers | No |
| Gender | Male |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Male patients with diagnosis of testicular, retroperitoneum or mediastinal primary tumor. - 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. - Medical records of the disease and treatment Exclusion Criteria: - Female patients diagnosed with ovary germ cell tumor - Male patients diagnosed with germ cell tumor in other locations. |
| Country | Name | City | State |
|---|---|---|---|
| Brazil | CPO - Pucrs | Porto Alegre | Rio Grande Do Sul |
| Brazil | Hospital Israelita Albert Einstein | São Paulo | |
| Brazil | Hospital São José | São Paulo | |
| Brazil | ICESP | São Paulo |
| Lead Sponsor | Collaborator |
|---|---|
| Latin American Cooperative Oncology Group |
Brazil,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Brazilian multicenter database in order to collect and analyze data from diagnosis and treatment of patients with germ cell tumor | From 2000 to 2025 | ||
| Secondary | Description of demographic characteristics of testicular germ cell tumor patients in Brazil | From 2000 to 2025 | ||
| Secondary | The clinical and pathological characteristics of testicular germ cell tumor patients in Brazil. | From 2000 to 2025 | ||
| Secondary | Treatment according to staging and relapse of patients diagnosed with testicular germ cell tumor in Brazil | From 2000 to 2025 | ||
| Secondary | Disease free survival of patients diagnosed with germ cell tumor stage 1. | From 2000 to 2025 | ||
| Secondary | Overall survival of patients diagnosed with germ cell tumor stage 1. | From 2000 to 2025 | ||
| Secondary | Disease free survival of patients diagnosed with germ cell tumor stages 2 and 3. | From 2000 to 2025 | ||
| Secondary | Overall survival of patients diagnosed with germ cell tumor stages 2 and 3. | From 2000 to 2025 | ||
| Secondary | 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. | From 2000 to 2025 | ||
| Secondary | 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 | From 2000 to 2025 | ||
| Secondary | Disease free survival of patients diagnosed with disease relapse after first line chemotherapy | From 2000 to 2025 | ||
| Secondary | Overall survival of patients diagnosed with disease relapse after first line chemotherapy | From 2000 to 2025 | ||
| Secondary | Prognostic model after first line treatment failure with cisplatin, stablished by the International Prognostic Factors Study Group in brazilian patients. | From 2000 to 2025 |
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