Recruiting

Genetic Testing

Sponsor:

Memorial Sloan Kettering Cancer Center

Code:

NCT03922893

Conditions

Cancer

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

Interventions

Family History Information

ORAGENE

Blood

Skin Biopsy

Study Details

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.

Conditions

Cancer

Study ID

NCT03922893

Start date

Apr 17, 2019

Status verified date

Dec, 2025

Completion date

Apr, 2029

Anticipated

Primary completion date

Apr, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

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.

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.

Study Design

Enrollment

1500 participants

Anticipated

Interventions and Outcome Measures

Arms

Proband

First individual in a family to consent to this protocol

Family Member Participants

Family members of the proband will be approached to consent to this protocol

Interventions

Family History Information

The family history ascertainment focuses on self-reported family history of first-, second-, and third-degree family members, including types of malignancies/ pre-malignant lesions and age at diagnosis.

ORAGENE

Approximately 2-4mL of saliva may be collected in specialized Oragene DNA Self-Collection Kit tubes or buccal swab-based collection devices.

Blood

For select participants, 1-2 tubes of blood will be drawn for DNA and RNA analysis

Skin Biopsy

In certain circumstances, for Memorial Sloan Kettering participants and their family members, it may be necessary to obtain a skin biopsy.

Primary outcome measure

  • Discovery of novel cancer susceptibility genes [ Time Frame: Up to 10 years ]

Central Contacts and Locations

Central contacts

Kenneth Offit, MD, MPH

646-888-4059offitk@mskcc.org

Mark Robson, MD

646-888-5486robsonm@mskcc.org

Locations

Memorial Sloan Kettering Basking Ridge (Consent only)

Recruiting

Basking Ridge, New Jersey, United States, 07920

Contacts

Kenneth Offit, MD, MPH

646-888-4059

Memorial Sloan Kettering Monmouth (Consent only)

Recruiting

Middletown, New Jersey, United States, 07748

Contacts

Kenneth Offit, MD, MPH

646-888-4059

Memorial Sloan Kettering Bergen (Consent only )

Recruiting

Montvale, New Jersey, United States, 07645

Contacts

Kenneth Offit, MD, MPH

646-888-4059

Memorial Sloan Kettering Cancer Center @ Commack (Consent Only)

Recruiting

Commack, New York, United States, 11725

Contacts

Kenneth Offit, MD, MPH

646-888-4059

Memorial Sloan Kettering Westchester (Consent only)

Recruiting

Harrison, New York, United States, 10604

Contacts

Kenneth Offit, MD, MPH

646-888-4059

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

Contacts

Kenneth Offit, MD, MPH

646-888-4059

Memorial Sloan Kettering Nassau (Consent only)

Recruiting

Uniondale, New York, United States, 11553

Contacts

Kenneth Offit, MD, MPH

646-888-4059

More Information

Sponsor

Memorial Sloan Kettering Cancer Center

Last update posted

Dec 15, 2025

Last verified

Dec, 2025

Keywords

  • Genetic evaluation
  • Germline genetic variant
  • Genetic cancer
  • Memorial Sloan Kettering Cancer Center
  • 19-133

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center on 2025-12-15.