NCT02863003

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,315

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2016

Longer than P75 for all trials

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 7, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 11, 2016

Completed
21 days until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

December 27, 2021

Status Verified

August 1, 2021

Enrollment Period

3.2 years

First QC Date

July 7, 2016

Last Update Submit

December 23, 2021

Conditions

Outcome Measures

Primary Outcomes (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 Outcomes (12)

  • 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

  • +7 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • Female patients diagnosed with ovary germ cell tumor
  • Male patients diagnosed with germ cell tumor in other locations.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

CPO - Pucrs

Porto Alegre, Rio Grande do Sul, Brazil

Location

Hospital Israelita Albert Einstein

São Paulo, Brazil

Location

Hospital São José

São Paulo, Brazil

Location

ICESP

São Paulo, Brazil

Location

MeSH Terms

Conditions

Neoplasms, Germ Cell and Embryonal

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasms

Study Officials

  • Gustavo Werutsky, MD

    Latin American Cooperative Oncology Group

    STUDY DIRECTOR
  • Diogo Bastos, MD

    Instituto do Cancer do Estado de São Paulo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
16 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 7, 2016

First Posted

August 11, 2016

Study Start

September 1, 2016

Primary Completion

December 1, 2019

Study Completion

December 1, 2020

Last Updated

December 27, 2021

Record last verified: 2021-08

Locations