Multicenter Database of Patients With Germ Cell Tumor | NCT02863003

Studies
Multicenter Database of Patients With Germ Cell Tumor

NCT02863003

Sponsor

Latin American Cooperative Oncology Group

Status

Completed

Last Update Posted

Dec 27, 2021Actual

Enrollment

1,315Actual

Phase

Not provided

Conditions

Neoplasms, Germ Cell and Embryonal

Interventions

Not provided

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2016

Primary Completion Date

Dec 2019Actual

Completion Date

Dec 2020Actual

First Submitted Date

Jul 7, 2016

First Submission Date that Met QC Criteria

Aug 8, 2016

First Posted Date

Aug 11, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 23, 2021

Last Update Posted Date

Dec 27, 2021Actual

Description Module

Brief Summary

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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

16 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,315Actual

Outcomes Module

Primary Outcomes

Measure	Description	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 Outcomes

Measure	Description	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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Gustavo Werutsky, MD	Latin American Cooperative Oncology Group	Study Director
Diogo Bastos, MD	Instituto do Cancer do Estado de São Paulo	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CPO - Pucrs		Porto Alegre	Rio Grande do Sul		Brazil
Hospital Israelita Albert Einstein

Condition Browse Module

MeSH Terms

ID	Term
D009373	Neoplasms, Germ Cell and Embryonal

Ancestor Terms

ID	Term
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided