Multicenter Database of Patients With Germ Cell Tumor

Multicenter Database of Patients With Germ Cell Tumor in Order to Characterize Clinicopathologically and to Evaluate Cancer Treatment Outcomes

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

Study Overview

• Status: Completed
• Conditions: Neoplasms, Germ Cell and Embryonal

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.

• Study Type: Observational
• Enrollment (Actual): 1315

Contacts and Locations

Study Locations

• Brazil
  • São Paulo, Brazil
    • Hospital Israelita Albert Einstein
  • São Paulo, Brazil
    • ICESP
  • São Paulo, Brazil
    • Hospital Sao Jose
  • Rio Grande Do Sul
    • Porto Alegre, Rio Grande Do Sul, Brazil
      • CPO - Pucrs

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

Men with diagnosis of testicular, retroperitonium or mediastinal primary tumor.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
Description of demographic characteristics of testicular germ cell tumor patients in Brazil	From 2000 to 2025
The clinical and pathological characteristics of testicular germ cell tumor patients in Brazil.	From 2000 to 2025
Treatment according to staging and relapse of patients diagnosed with testicular germ cell tumor in Brazil	From 2000 to 2025
Disease free survival of patients diagnosed with germ cell tumor stage 1.	From 2000 to 2025
Overall survival of patients diagnosed with germ cell tumor stage 1.	From 2000 to 2025
Disease free survival of patients diagnosed with germ cell tumor stages 2 and 3.	From 2000 to 2025
Overall survival of patients diagnosed with germ cell tumor stages 2 and 3.	From 2000 to 2025
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
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
Disease free survival of patients diagnosed with disease relapse after first line chemotherapy	From 2000 to 2025
Overall survival of patients diagnosed with disease relapse after first line chemotherapy	From 2000 to 2025
Prognostic model after first line treatment failure with cisplatin, stablished by the International Prognostic Factors Study Group in brazilian patients.	From 2000 to 2025

Collaborators and Investigators

• Sponsor: Latin American Cooperative Oncology Group
• Investigators: Study Director: Gustavo Werutsky, MD, Latin American Cooperative Oncology Group; Principal Investigator: Diogo Bastos, MD, Instituto do Cancer do Estado de Sao Paulo

Study record dates

Study Major Dates

• Study Start: September 1, 2016
• Primary Completion (Actual): December 1, 2019
• Study Completion (Actual): December 1, 2020

Study Registration Dates

• First Submitted: July 7, 2016
• First Submitted That Met QC Criteria: August 8, 2016
• First Posted (Estimate): August 11, 2016

Study Record Updates

• Last Update Posted (Actual): December 27, 2021
• Last Update Submitted That Met QC Criteria: December 23, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Germ Cell and Embryonal
• Other Study ID Numbers: LACOG 0515