Clinical trial NCT03922893: Discovering New Genetic Markers in Adults and Children Who May Be At Risk for Hereditary Forms of Cancer
Official title: Discovery and Characterization of Susceptibility Genes in Adults and Children With Suspected Hereditary Cancer Predisposition
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cancer
Keywords: Genetic evaluation
Germline genetic variant
Genetic cancer
Memorial Sloan Kettering Cancer Center
19-133
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2019-04-22
Enrollment: 1500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Discovery of novel cancer susceptibility genes
timeFrame: Up to 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering Basking Ridge (Consent only)
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan Kettering Monmouth (Consent only)
state: New Jersey
city: Montvale
country: United States
facility: Memorial Sloan Kettering Bergen (Consent only )
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Cancer Center @ Commack (Consent Only)
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester (Consent only)
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Uniondale
country: United States
facility: Memorial Sloan Kettering Nassau (Consent only)
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Kenneth Offit, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: