Germ Cell Tumor and Testicular Tumor DNA Registry

NCT ID: NCT02099734

Last Updated: 2025-07-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-01-31

Study Completion Date

2026-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Germ Cell Tumor Testicular Tumor

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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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,

Questionnaires

Intervention Type BEHAVIORAL

sample of blood or saliva

Intervention Type 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.

B: family members of Group A

relatives of patients with GCTs or testicular tumors

Questionnaires

Intervention Type BEHAVIORAL

sample of blood or saliva

Intervention Type 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.

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

Questionnaires

Intervention Type BEHAVIORAL

sample of blood or saliva

Intervention Type 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.

Interventions

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Questionnaires

Intervention Type BEHAVIORAL

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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Darren Feldman, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

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Memorial Sloan Kettering Basking Ridge

Basking Ridge, New Jersey, United States

Site Status RECRUITING

Memorial Sloan Kettering Monmouth

Middletown, New Jersey, United States

Site Status RECRUITING

Memorial Sloan Kettering Bergen

Montvale, New Jersey, United States

Site Status RECRUITING

Cold Springs Harbor Laboratory (Specimen Analysis)

Cold Spring Harbor, New York, United States

Site Status NOT_YET_RECRUITING

Memorial Sloan Kettering Commack

Commack, New York, United States

Site Status RECRUITING

Memorial Sloan Kettering Westchester

Harrison, New York, United States

Site Status RECRUITING

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Site Status RECRUITING

Memorial Sloan Kettering Nassau

Uniondale, New York, United States

Site Status NOT_YET_RECRUITING

Countries

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United States

Central Contacts

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Darren Feldman, MD

Role: CONTACT

646-422-4491

Joel Sheinfeld, MD

Role: CONTACT

646-422-4311

Facility Contacts

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Darren Feldman, MD

Role: primary

646-422-4491

Darren Feldman, MD

Role: primary

646-422-4491

Darren Feldman, MD

Role: primary

646-422-4491

Richard McCombie, PhD

Role: primary

516-367-8800

Darren Feldman, MD

Role: primary

646-422-4491

Darren Feldman, MD

Role: primary

646-422-4491

Darren Feldman, MD

Role: primary

646-422-4491

Joel Sheinfeld, MD

Role: backup

646-422-4311

Darren Feldman, MD

Role: primary

646-422-4491

Related Links

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http://www.mskcc.org/

Memorial Sloan Kettering Cancer Center

Other Identifiers

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14-016

Identifier Type: -

Identifier Source: org_study_id

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