Germ Cell Tumor and Testicular Tumor DNA Registry

Germ Cell Tumor Clinical Trial

Official title:

Germ Cell Tumor and Testicular Tumor DNA Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02099734
• Other study ID #: 14-016
• Status: Recruiting
• Start date: January 2014
• Est. completion date: January 2026

Study information

• Verified date: July 2023
• Source: Memorial Sloan Kettering Cancer Center
• Contact: Darren Feldman, MD
• Phone: 646-422-4491
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study is being done to create a registry to help us learn more about germ cell tumors (GCT) and other testicular tumors. The registry will include people with these tumors and also relatives and unrelated people without these tumors. This study will help us learn more about the prevention, diagnosis, treatment and outcome of these tumors. Studying relatives of patients and people unrelated to patients with GCT and other testicular tumors will help us understand why some people get these tumors and why some people don't.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: January 2026
• Est. primary completion date: January 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Case Cohort

• Must be = 18 years of age AND

• Must be an English-speaker AND

• Must have a diagnosis or suspicion of germ cell tumor and/or a testicular mass

Family Member Cohort

• Must be = 18 years of age AND

• Must be an English-speaker AND

• Must be a blood relative of the proband. Family members of probands are eligible. These individuals need not have a diagnosis of GCT-TT, as they will be used for segregation analysis of suspected variants found in the proband.

Control Cohort

• Must be = 18 years of age AND

• Must be an English-speaker AND

• Must not have a personal history of cancer, with the exception of non-melanoma skin cancer, AND

• Must not have a family history of germ cell tumor or testicular tumor AND

• Must not be a blood relative of controls enrolled in this study

Exclusion Criteria:

Related Conditions & MeSH terms

• Germ Cell Tumor
• Neoplasms
• Neoplasms, Germ Cell and Embryonal
• Testicular Neoplasms
• Testicular Tumor

Intervention

Behavioral:
• Questionnaires

Other:
• sample of blood or saliva
A sample of blood or saliva will be obtained for DNA extraction. Approximately 2-4 tubes of blood will be collected or one tablespoon of saliva. If a participant has already provided a DNA sample for another MSKCC IRB approved protocol, they may not need to provide an additional sample.

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Basking Ridge	Basking Ridge	New Jersey
United States	Cold Springs Harbor Laboratory (Specimen Analysis)	Cold Spring Harbor	New York
United States	Memorial Sloan Kettering Commack	Commack	New York
United States	Memorial Sloan Kettering Westchester	Harrison	New York
United States	Memorial Sloan Kettering Monmouth	Middletown	New Jersey
United States	Memorial Sloan Kettering Bergen	Montvale	New Jersey
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	Memorial Sloan Kettering Nassau	Uniondale	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	creation of a Germ Cell Tumor and testicular tumor registry	We will collect clinical data including diagnosis date, pathology, family history, and risk factors in patients with GCT-TT.	5 years

External Links

•   Memorial Sloan Kettering Cancer Center