Germ Cell Tumor and Testicular Tumor DNA Registry

Recruiting

• Conditions: Germ Cell Tumor; Testicular Tumor
• Interventions: Behavioral: Questionnaires; Other: sample of blood or saliva

• Registration Number: NCT02099734
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-03-26
• Study First Submitted QC: 2014-03-26
• Study First Posted: 2014-03-31
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-03
• Last Update Posted: 2024-07-05
• Primary Completion: 2026-01
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
A: suspicion of germ cell tumor and/or a testicular mass	Questionnaires	patients with testicular GCTs and non-GCT testicular tumors, extragonadal male GCTs, and female GCTs,
B: family members of Group A	Questionnaires	relatives of patients with GCTs or testicular tumors
B: family members of Group A	sample of blood or saliva	relatives of patients with GCTs or testicular tumors
A: suspicion of germ cell tumor and/or a testicular mass	sample of blood or saliva	patients with testicular GCTs and non-GCT testicular tumors, extragonadal male GCTs, and female GCTs,
C: healthy controls unrelated to Group A or B	Questionnaires	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
C: healthy controls unrelated to Group A or B	sample of blood or saliva	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

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (8)

Memorial Sloan Kettering Basking Ridge; 🇺🇸 Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Monmouth; 🇺🇸 Middletown, New Jersey, United States

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States

Memorial Sloan Kettering Bergen; 🇺🇸 Montvale, New Jersey, United States

Cold Springs Harbor Laboratory (Specimen Analysis); 🇺🇸 Cold Spring Harbor, New York, United States

Memorial Sloan Kettering Commack; 🇺🇸 Commack, New York, United States

Memorial Sloan Kettering Westchester; 🇺🇸 Harrison, New York, United States

Memorial Sloan Kettering Nassau; 🇺🇸 Uniondale, New York, United States