Discovering New Genetic Markers in Adults and Children Who May Be At Risk for Hereditary Forms of Cancer

Recruiting

• Conditions: Cancer
• Interventions: Other: Family History Information; Genetic: ORAGENE; Genetic: Blood; Other: Skin Biopsy

• Registration Number: NCT03922893
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief Summary

This study is being done to attempt to identify genetic mutations or other gene-based variations in adults and children who have cancer, or are likely to develop an inherited form of cancer, and potentially reduce their risk for cancer or treat the cancer earlier.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2019-04-17
• Study First Submitted: 2019-04-18
• Study First Submitted QC: 2019-04-18
• Study First Posted: 2019-04-22
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-11
• Last Update Posted: 2024-03-12
• Primary Completion: 2029-04
• Study Completion: 2029-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1500

Inclusion Criteria

• Individuals who have undergone clinical and/or research genetic evaluation, found to have or not have a germline genetic variant (pathogenic, likely pathogenic, variant of uncertain/unknown significance, likely benign).
• Individuals with or without a personal history of malignant or pre-malignant lesions who demonstrate: a) clinical findings suggestive of a genetic cancer susceptibility syndrome including very early age at onset, multiple primary malignancies, or other features; and/or b) family histories suggestive of a genetic cancer susceptibility syndrome, or c) other features suggesting inherited etiology of malignancy as determined by the PI.
• Family members of the above participants. Both children (with parental consent as age appropriate) and adults are eligible to participation.
• Individuals may or may not be enrolled MSK patients; probands may be referred to (or self-referred to) the study and may be enrolled at discretion of the PI and if able to provide informed consent.
• Biospecimens derived from deceased family members may be used for research in this study if consent if provided by the executor of the estate of that individual.

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Exclusion Criteria

• Patients will be excluded from this study if he/she has physical, cognitive or psychiatric conditions that interfere with ability to give meaningful informed consent.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Proband	Blood	First individual in a family to consent to this protocol
Family Member Participants	Blood	Family members of the proband will be approached to consent to this protocol
Family Member Participants	Skin Biopsy	Family members of the proband will be approached to consent to this protocol
Proband	ORAGENE	First individual in a family to consent to this protocol
Proband	Skin Biopsy	First individual in a family to consent to this protocol
Family Member Participants	Family History Information	Family members of the proband will be approached to consent to this protocol
Family Member Participants	ORAGENE	Family members of the proband will be approached to consent to this protocol
Proband	Family History Information	First individual in a family to consent to this protocol

Primary Outcome Measures

Name	Time	Method
Discovery of novel cancer susceptibility genes	Up to 10 years

Trial Locations

Locations (7)

Memorial Sloan Kettering Monmouth (Consent only); 🇺🇸 Middletown, New Jersey, United States

Memorial Sloan Kettering Basking Ridge (Consent only); 🇺🇸 Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Bergen (Consent only ); 🇺🇸 Montvale, New Jersey, United States

Memorial Sloan Kettering Cancer Center @ Commack (Consent Only); 🇺🇸 Commack, New York, United States

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

Memorial Sloan Kettering Westchester (Consent only); 🇺🇸 Harrison, New York, United States

Memorial Sloan Kettering Nassau (Consent only); 🇺🇸 Uniondale, New York, United States