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Multicenter Database of Patients With Germ Cell Tumor

Sponsor
Latin American Cooperative Oncology Group (Other)
Overall Status
Completed
CT.gov ID
NCT02863003
Collaborator
(none)
1,315
Enrollment
4
Locations
51
Duration (Months)
328.8
Patients Per Site
6.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational [Patient Registry]
    Actual Enrollment :
    1315 participants
    Observational Model:
    Cohort
    Time Perspective:
    Other
    Official Title:
    Multicenter Database of Patients With Germ Cell Tumor in Order to Characterize Clinicopathologically and to Evaluate Cancer Treatment Outcomes
    Study Start Date :
    Sep 1, 2016
    Actual Primary Completion Date :
    Dec 1, 2019
    Actual Study Completion Date :
    Dec 1, 2020

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. Description of demographic characteristics of testicular germ cell tumor patients in Brazil [From 2000 to 2025]

    2. The clinical and pathological characteristics of testicular germ cell tumor patients in Brazil. [From 2000 to 2025]

    3. Treatment according to staging and relapse of patients diagnosed with testicular germ cell tumor in Brazil [From 2000 to 2025]

    4. Disease free survival of patients diagnosed with germ cell tumor stage 1. [From 2000 to 2025]

    5. Overall survival of patients diagnosed with germ cell tumor stage 1. [From 2000 to 2025]

    6. Disease free survival of patients diagnosed with germ cell tumor stages 2 and 3. [From 2000 to 2025]

    7. Overall survival of patients diagnosed with germ cell tumor stages 2 and 3. [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. [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 [From 2000 to 2025]

    10. Disease free survival of patients diagnosed with disease relapse after first line chemotherapy [From 2000 to 2025]

    11. Overall survival of patients diagnosed with disease relapse after first line chemotherapy [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. [From 2000 to 2025]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CPO - Pucrs Porto Alegre Rio Grande Do Sul Brazil
    2 Hospital Israelita Albert Einstein São Paulo Brazil
    3 Hospital São José São Paulo Brazil
    4 ICESP São Paulo Brazil

    Sponsors and Collaborators

    • 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 São Paulo

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Latin American Cooperative Oncology Group
    ClinicalTrials.gov Identifier:
    NCT02863003
    Other Study ID Numbers:
    • LACOG 0515
    First Posted:
    Aug 11, 2016
    Last Update Posted:
    Dec 27, 2021
    Last Verified:
    Aug 1, 2021
    Additional relevant MeSH terms:
    Neoplasms, Germ Cell and Embryonal

    Study Results

    No Results Posted as of Dec 27, 2021