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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 : February 1, 2018
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

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.

Condition or disease Intervention/treatment
Germ Cell Tumor Testicular Tumor Behavioral: Questionnaires Other: sample of blood or saliva

Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Germ Cell Tumor and Testicular Tumor DNA Registry
Actual Study Start Date : January 2014
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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.


Biospecimen Retention:   Samples With DNA
blood saliva


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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).
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:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02099734


Contacts
Contact: Darren Feldman, MD 646-422-4491
Contact: Joel Sheinfeld, MD 646-422-4311

Locations
United States, New Jersey
Memoral Sloan Kettering Basking Ridge Recruiting
Basking Ridge, New Jersey, United States
Contact: Darren Feldman, MD    646-422-4491      
Memorial Sloan Kettering Monmouth Recruiting
Middletown, New Jersey, United States, 07748
Contact: Darren Feldman, MD    646-422-4491      
United States, New York
Memorial Sloan Kettering Commack Recruiting
Commack, New York, United States, 11725
Contact: Darren Feldman, MD    646-422-4491      
Memorial Sloan Kettering Westchester Recruiting
Harrison, New York, United States, 10604
Contact: Darren Feldman, MD    646-422-4491      
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Darren Feldman, MD    646-422-4491      
Contact: Joel Sheinfeld, MD    646-422-4311      
Principal Investigator: Darren Feldman, MD         
Memorial Sloan Kettering Rockville Centre Recruiting
Rockville Centre, New York, United States, 11570
Contact: Darren Feldman, MD    646-422-4491      
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
Principal Investigator: Darren Feldman, MD Memorial Sloan Kettering Cancer Center

Additional Information:
Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT02099734     History of Changes
Other Study ID Numbers: 14-016
First Posted: March 31, 2014    Key Record Dates
Last Update Posted: February 1, 2018
Last Verified: January 2018

Keywords provided by Memorial Sloan Kettering Cancer Center:
14-016

Additional relevant MeSH terms:
Testicular Neoplasms
Neoplasms
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Endocrine Gland Neoplasms
Neoplasms by Site
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Endocrine System Diseases
Testicular Diseases
Gonadal Disorders