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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03922893
Other study ID # 19-133
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 17, 2019
Est. completion date April 2029

Study information

Verified date March 2024
Source Memorial Sloan Kettering Cancer Center
Contact Kenneth Offit, MD, MPH
Phone 646-888-4059
Email offitk@mskcc.org
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 1500
Est. completion date April 2029
Est. primary completion date April 2029
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States Memorial Sloan Kettering Basking Ridge (Consent only) Basking Ridge New Jersey
United States Memorial Sloan Kettering Cancer Center @ Commack (Consent Only) Commack New York
United States Memorial Sloan Kettering Westchester (Consent only) Harrison New York
United States Memorial Sloan Kettering Monmouth (Consent only) Middletown New Jersey
United States Memorial Sloan Kettering Bergen (Consent only ) Montvale New Jersey
United States Memorial Sloan Kettering Cancer Center New York New York
United States Memorial Sloan Kettering Nassau (Consent only) Uniondale New York

Sponsors (1)

Lead Sponsor Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Discovery of novel cancer susceptibility genes Up to 10 years
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