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

Cancer Clinical Trial

Official title:

Discovery and Characterization of Susceptibility Genes in Adults and Children With Suspected Hereditary Cancer Predisposition

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03922893
• Other study ID #: 19-133
• Status: Recruiting
• 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
• 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.

Related Conditions & MeSH terms

• Cancer

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

External Links

•   Memorial Sloan Kettering Cancer Center