Clinical trial NCT02863003: Multicenter Database of Patients With Germ Cell Tumor
Official title: Multicenter Database of Patients With Germ Cell Tumor in Order to Characterize Clinicopathologically and to Evaluate Cancer Treatment Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neoplasms, Germ Cell and Embryonal
Lead sponsor: Latin American Cooperative Oncology Group
Sponsor class: OTHER
First posted: 2016-08-11
Enrollment: 1315
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Men with diagnosis of testicular, retroperitonium or mediastinal primary tumor.

Brief summary: Retrospective and prospective cohort of patients with germ cell tumor in treatment.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
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
Secondary outcomes:
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
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: CPO - Pucrs
state: Rio Grande Do Sul
city: São Paulo
country: Brazil
facility: Hospital Israelita Albert Einstein
city: São Paulo
country: Brazil
facility: Hospital São José
city: São Paulo
country: Brazil
facility: ICESP
Study officials:
affiliation: Latin American Cooperative Oncology Group
name: Gustavo Werutsky, MD
role: STUDY_DIRECTOR
affiliation: Instituto do Cancer do Estado de São Paulo
name: Diogo Bastos, MD
role: PRINCIPAL_INVESTIGATOR
References: