Discovering New Genetic Markers in Adults and Children Who May Be At Risk for Hereditary Forms of Cancer
Discovery and Characterization of Susceptibility Genes in Adults and Children With Suspected Hereditary Cancer Predisposition
1 other identifier
observational
1,500
1 country
7
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2019
Longer than P75 for all trials
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 17, 2019
CompletedFirst Submitted
Initial submission to the registry
April 18, 2019
CompletedFirst Posted
Study publicly available on registry
April 22, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2029
December 15, 2025
December 1, 2025
10 years
April 18, 2019
December 8, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Discovery of novel cancer susceptibility genes
Up to 10 years
Study Arms (2)
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
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.
Approximately 2-4mL of saliva may be collected in specialized Oragene DNA Self-Collection Kit tubes or buccal swab-based collection devices.
For select participants, 1-2 tubes of blood will be drawn for DNA and RNA analysis
In certain circumstances, for Memorial Sloan Kettering participants and their family members, it may be necessary to obtain a skin biopsy.
Eligibility Criteria
Potential participants will be identified by members of the Clinical Genetics Service from the following sources: a) MSK patients previously tested through MSK IMPACT #12-245 protocol; b) MSK patients referred to the Clinical Genetics Service by an MSK physician, outside physician, or self-referral; c) non-MSKCC patients referred or self-referred to the Clinical Genetics Service or directly to the P.I. and identified as candidates for participation in this study; d) family members of probands identified by the study team to be informative for research purposed.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Memorial Sloan Kettering Cancer Centerlead
- New York Genome Centercollaborator
Study Sites (7)
Memorial Sloan Kettering Basking Ridge (Consent only)
Basking Ridge, New Jersey, 07920, United States
Memorial Sloan Kettering Monmouth (Consent only)
Middletown, New Jersey, 07748, United States
Memorial Sloan Kettering Bergen (Consent only )
Montvale, New Jersey, 07645, United States
Memorial Sloan Kettering Cancer Center @ Commack (Consent Only)
Commack, New York, 11725, United States
Memorial Sloan Kettering Westchester (Consent only)
Harrison, New York, 10604, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Memorial Sloan Kettering Nassau (Consent only)
Uniondale, New York, 11553, United States
Related Links
Biospecimen
Collection of biological specimens (DNA, RNA, tissue)
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kenneth Offit, MD, MPH
Memorial Sloan Kettering Cancer Center
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 18, 2019
First Posted
April 22, 2019
Study Start
April 17, 2019
Primary Completion (Estimated)
April 1, 2029
Study Completion (Estimated)
April 1, 2029
Last Updated
December 15, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will share
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.