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Multicenter Database of Patients With Germ Cell Tumor

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ClinicalTrials.gov Identifier: NCT02863003
Recruitment Status : Not yet recruiting
First Posted : August 11, 2016
Last Update Posted : August 11, 2016
Sponsor:
Information provided by (Responsible Party):
Latin American Cooperative Oncology Group

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

Condition or disease
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 [Patient Registry]
Estimated Enrollment : 1500 participants
Observational Model: Cohort
Target Follow-Up Duration: 16 Years
Official Title: Multicenter Database of Patients With Germ Cell Tumor in Order to Characterize Clinicopathologically and to Evaluate Cancer Treatment Outcomes
Study Start Date : September 2016
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020



Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Men with diagnosis of testicular, retroperitonium or mediastinal primary tumor.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02863003


Contacts
Contact: Laura Voelcker 55 51 3384 5334 laura.voelcker@lacog.org.br
Contact: Raíra Maschmann 55 51 3384 5334 raira.maschmann@lacog.org.br

Locations
Brazil
CPO - Pucrs Not yet recruiting
Porto Alegre, Rio Grande do Sul, Brazil
Contact: Virginia Webber         
Principal Investigator: André Fay, MD         
Hospital Israelita Albert Einstein Not yet recruiting
São Paulo, Brazil
Contact: Fernanda Cardoso         
Principal Investigator: Oren Smaletz, MD         
Hospital São José Not yet recruiting
São Paulo, Brazil
Contact: Cristiane Ibrahim         
Principal Investigator: Fábio Schutz, MD         
ICESP Not yet recruiting
São Paulo, Brazil
Contact: Bárbara Penna         
Principal Investigator: Diogo Bastos, MD         
Principal Investigator: Carlos Dzik, MD         
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

Responsible Party: Latin American Cooperative Oncology Group
ClinicalTrials.gov Identifier: NCT02863003     History of Changes
Other Study ID Numbers: LACOG 0515
First Posted: August 11, 2016    Key Record Dates
Last Update Posted: August 11, 2016
Last Verified: June 2016

Additional relevant MeSH terms:
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms