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Germ Cell Tumor and Testicular Tumor DNA Registry

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ClinicalTrials.gov Identifier: NCT02099734
Recruitment Status : Recruiting
First Posted : March 31, 2014
Last Update Posted : January 5, 2021
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Tracking Information
First Submitted Date March 26, 2014
First Posted Date March 31, 2014
Last Update Posted Date January 5, 2021
Actual Study Start Date January 2014
Estimated Primary Completion Date January 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 26, 2014)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Germ Cell Tumor and Testicular Tumor DNA Registry
Official Title Germ Cell Tumor and Testicular Tumor DNA Registry
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
blood saliva
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).
Condition
  • Germ Cell Tumor
  • 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.
Study Groups/Cohorts
  • 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,
    Interventions:
    • Behavioral: Questionnaires
    • Other: sample of blood or saliva
  • B: family members of Group A
    relatives of patients with GCTs or testicular tumors
    Interventions:
    • 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
    Interventions:
    • Behavioral: Questionnaires
    • Other: sample of blood or saliva
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: March 26, 2014)
1000
Original Estimated Enrollment Same as current
Estimated Study Completion Date January 2022
Estimated Primary Completion Date January 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria

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:

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Darren Feldman, MD 646-422-4491
Contact: Joel Sheinfeld, MD 646-422-4311
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02099734
Other Study ID Numbers 14-016
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Memorial Sloan Kettering Cancer Center
Study Sponsor Memorial Sloan Kettering Cancer Center
Collaborators Not Provided
Investigators
Principal Investigator: Darren Feldman, MD Memorial Sloan Kettering Cancer Center
PRS Account Memorial Sloan Kettering Cancer Center
Verification Date January 2021