Germ Cell Tumor and Testicular Tumor DNA Registry

July 3, 2023 updated by: Memorial Sloan Kettering Cancer Center
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Darren Feldman, MD
  • Phone Number: 646-422-4491

Study Contact Backup

  • Name: Joel Sheinfeld, MD
  • Phone Number: 646-422-4311

Study Locations

  • United States
    • New Jersey
      • Basking Ridge, New Jersey, United States
        • Recruiting
        • Memorial Sloan Kettering Basking Ridge
        • Contact:
          • Darren Feldman, MD
          • Phone Number: 646-422-4491
      • Middletown, New Jersey, United States, 07748
        • Recruiting
        • Memorial Sloan Kettering Monmouth
        • Contact:
          • Darren Feldman, MD
          • Phone Number: 646-422-4491
      • Montvale, New Jersey, United States, 07645
        • Recruiting
        • Memorial Sloan Kettering Bergen
        • Contact:
          • Darren Feldman, MD
          • Phone Number: 646-422-4491
    • New York
      • Cold Spring Harbor, New York, United States, 11724
        • Not yet recruiting
        • Cold Springs Harbor Laboratory (Specimen Analysis)
        • Contact:
          • Richard McCombie, PhD
          • Phone Number: 516-367-8800
      • Commack, New York, United States, 11725
        • Recruiting
        • Memorial Sloan Kettering Commack
        • Contact:
          • Darren Feldman, MD
          • Phone Number: 646-422-4491
      • Harrison, New York, United States, 10604
        • Recruiting
        • Memorial Sloan Kettering Westchester
        • Contact:
          • Darren Feldman, MD
          • Phone Number: 646-422-4491
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan Kettering Cancer Center
        • Contact:
          • Darren Feldman, MD
          • Phone Number: 646-422-4491
        • Contact:
          • Joel Sheinfeld, MD
          • Phone Number: 646-422-4311
        • Principal Investigator:
          • Darren Feldman, MD
      • Uniondale, New York, United States, 11553
        • Not yet recruiting
        • Memorial Sloan Kettering Nassau
        • Contact:
          • Darren Feldman, MD
          • Phone Number: 646-422-4491

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

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).

Description

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:

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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
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.
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
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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Investigators

  • Principal Investigator: Darren Feldman, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2014

Primary Completion (Estimated)

January 1, 2026

Study Completion (Estimated)

January 1, 2026

Study Registration Dates

First Submitted

March 26, 2014

First Submitted That Met QC Criteria

March 26, 2014

First Posted (Estimated)

March 31, 2014

Study Record Updates

Last Update Posted (Actual)

July 5, 2023

Last Update Submitted That Met QC Criteria

July 3, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-016 (CTSU)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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