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OpenTrials
Completed

NCT Number: NCT02863003

Multicenter Database of Patients With Germ Cell Tumor

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

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Key information

Conditions

Neoplasms, Germ Cell and Embryonal Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

CPO - Pucrs, Porto Alegre, Rio Grande do Sul, Brazil

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Brazilian multicenter database in order to collect and analyze data from diagnosis and treatment of patients with germ cell tumor

    Time frame: From 2000 to 2025

Secondary outcomes

  1. Description of demographic characteristics of testicular germ cell tumor patients in Brazil

    Time frame: From 2000 to 2025

  2. The clinical and pathological characteristics of testicular germ cell tumor patients in Brazil.

    Time frame: From 2000 to 2025

  3. Treatment according to staging and relapse of patients diagnosed with testicular germ cell tumor in Brazil

    Time frame: From 2000 to 2025

  4. Disease free survival of patients diagnosed with germ cell tumor stage 1.

    Time frame: From 2000 to 2025

  5. Overall survival of patients diagnosed with germ cell tumor stage 1.

    Time frame: From 2000 to 2025

  6. Disease free survival of patients diagnosed with germ cell tumor stages 2 and 3.

    Time frame: From 2000 to 2025

  7. Overall survival of patients diagnosed with germ cell tumor stages 2 and 3.

    Time frame: From 2000 to 2025

  8. 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.

    Time frame: From 2000 to 2025

  9. 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

    Time frame: From 2000 to 2025

  10. Disease free survival of patients diagnosed with disease relapse after first line chemotherapy

    Time frame: From 2000 to 2025

  11. Overall survival of patients diagnosed with disease relapse after first line chemotherapy

    Time frame: From 2000 to 2025

  12. Prognostic model after first line treatment failure with cisplatin, stablished by the International Prognostic Factors Study Group in brazilian patients.

    Time frame: From 2000 to 2025

Sponsors and collaborators

Lead sponsor

Latin American Cooperative Oncology Group

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2019
Study completion
2020
First posted
Aug 11, 2016
Registry last updated
Dec 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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