Germ Cell Tumor and Testicular Tumor DNA Registry

Sponsor

Memorial Sloan Kettering Cancer Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT02099734

Collaborator

(none)

1,000

Enrollment

Locations

120

Anticipated Duration (Months)

125

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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	Phase
Germ Cell Tumor Testicular Tumor	Behavioral: Questionnaires Other: sample of blood or saliva

Study Design

Study Type:

Observational

Anticipated Enrollment :

1000 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

Germ Cell Tumor and Testicular Tumor DNA Registry

Actual Study Start Date :

Jan 1, 2014

Anticipated Primary Completion Date :

Jan 1, 2024

Anticipated Study Completion Date :

Jan 1, 2024

Arms and Interventions

Arm	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.

Arm

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

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Memoral Sloan Kettering Basking Ridge	Basking Ridge	New Jersey	United States
2	Memorial Sloan Kettering Monmouth	Middletown	New Jersey	United States	07748
3	Memorial Sloan Kettering Bergen	Montvale	New Jersey	United States	07645
4	Cold Springs Harbor Laboratory (Specimen Analysis)	Cold Spring Harbor	New York	United States	11724
5	Memorial Sloan Kettering Commack	Commack	New York	United States	11725
6	Memorial Sloan Kettering Westchester	Harrison	New York	United States	10604
7	Memorial Sloan Kettering Cancer Center	New York	New York	United States	10065
8	Memorial Sloan Kettering Nassau	Uniondale	New York	United States	11553