Genetic Marker Discovery for Hereditary Cancer

Recruiting at 10 trial locations

Overseen By Mark Robson, MD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Memorial Sloan Kettering Cancer Center

Disqualifiers: Physical, cognitive, psychiatric conditions

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

1500 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to discover new genetic markers that could help identify individuals at risk for hereditary forms of cancer. Researchers will study genetic mutations in both adults and children to find ways to reduce cancer risk or treat it earlier. Participants will provide blood or saliva samples using the ORAGENE collection kit for analysis. The trial seeks individuals who have undergone a genetic evaluation related to cancer, have a personal or family history suggesting a genetic cancer risk, or are family members of someone already participating. As an unphased study, this trial offers participants the chance to contribute to groundbreaking research that could lead to earlier cancer detection and prevention strategies.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Why are researchers excited about this trial?

Researchers are excited about this trial because it aims to uncover new genetic markers that can indicate a hereditary risk for cancer. Unlike traditional methods that focus on known genetic mutations, this study uses blood and saliva (ORAGENE) samples to potentially identify previously unknown markers. This could lead to earlier and more personalized cancer screening and prevention strategies for individuals and families, offering a new layer of understanding and intervention before cancer develops.

Who Is on the Research Team?

Kenneth Offit, MD, MPH

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Genetic Analysis

Participants undergo genetic testing to identify mutations or gene-based variations

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after genetic analysis

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Blood
• ORAGENE

How Is the Trial Designed?

Group I: Proband Experimental Treatment 4 Interventions

First individual in a family to consent to this protocol

Group II: Family Member Participants Experimental Treatment 4 Interventions

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

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

New York Genome Center

Collaborator

Trials

4

Recruited

2,300+