Germ Cell Tumor and Testicular Tumor DNA Registry

NCT02099734 | Recruiting

• 1 other identifier: 14-016
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 8

Brief 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.

Conditions

Germ Cell Tumor; Testicular Tumor

Keywords

14-016

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

A: suspicion of germ cell tumor and/or a testicular mass

patients with testicular GCTs and non-GCT testicular tumors, extragonadal male GCTs, and female GCTs,

Behavioral: Questionnaires; Other: sample of blood or saliva

B: family members of Group A

relatives of patients with GCTs or testicular tumors

Behavioral: Questionnaires; Other: sample of blood or saliva

C: healthy controls unrelated to Group A or B

healthy controls who are unrelated to Groups A or B and do not have a personal history of cancer nor a family history of GCT or non-GCT testicular tumors

Behavioral: Questionnaires; Other: sample of blood or saliva

Interventions

Questionnaires BEHAVIORAL

A: suspicion of germ cell tumor and/or a testicular mass; B: family members of Group A; C: healthy controls unrelated to Group A or B

sample of blood or saliva OTHER

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.

A: suspicion of germ cell tumor and/or a testicular mass; B: family members of Group A; C: healthy controls unrelated to Group A or B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

At MSKCC, the following outpatient clinics will be used to recruit GCT and testicular tumor cases and controls: Urology (Department of Surgery), Gynecologic Oncology (Department of Surgery) Clinical Genetics, Genitourinary Oncology (Department of Medicine), and Gynecologic Medical Oncology (Department of Medicine).

You may qualify if:

• 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

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (8)

Memorial Sloan Kettering Basking Ridge

Basking Ridge, New Jersey, United States

RECRUITING

Memorial Sloan Kettering Monmouth

Middletown, New Jersey, 07748, United States

RECRUITING

Memorial Sloan Kettering Bergen

Montvale, New Jersey, 07645, United States

RECRUITING

Cold Springs Harbor Laboratory (Specimen Analysis)

Cold Spring Harbor, New York, 11724, United States

NOT YET RECRUITING

Memorial Sloan Kettering Commack

Commack, New York, 11725, United States

RECRUITING

Memorial Sloan Kettering Westchester

Harrison, New York, 10604, United States

RECRUITING

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

RECRUITING

Memorial Sloan Kettering Nassau

Uniondale, New York, 11553, United States

NOT YET RECRUITING

Related Links

• Memorial Sloan Kettering Cancer Center

Biospecimen

Retention: SAMPLES WITH DNA

blood saliva

MeSH Terms

Conditions

Neoplasms, Germ Cell and Embryonal; Testicular Neoplasms

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Endocrine System Diseases; Testicular Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Darren Feldman, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Darren Feldman, MD

CONTACT

646-422-4491

Joel Sheinfeld, MD

CONTACT

646-422-4311

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2014
• First Posted: March 31, 2014
• Study Start: January 1, 2014
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028
• Last Updated: February 4, 2026

Record last verified: 2026-02

Locations

US (8)