MyRisk Hereditary Cancer Test for Cancer Syndromes

(FOCUS Trial)

Recruiting at 2 trial locations

Overseen By Steve Lopez, BA

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Weill Medical College of Cornell University

Disqualifiers: Hematologic cancer, Bone marrow transplant, others

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

Compensation: Varies

Number of Visits: Unknown

350 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether pregnant patients are interested in genetic testing to determine their risk of certain cancers. It aims to assess if offering cancer risk tests during routine prenatal visits is beneficial and could aid in early cancer prevention, particularly in underserved communities. The trial uses the MyRisk Hereditary Cancer Test to identify genes linked to cancer. Pregnant individuals receiving prenatal care at select New York hospitals and opting for standard prenatal genetic screening may be suitable candidates. As an unphased study, this trial provides a unique opportunity for participants to contribute to significant research that could influence future prenatal care practices.

Do I need to stop my current medications for this trial?

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

What prior data suggests that the MyRisk Hereditary Cancer Test is safe for use in pregnant patients?

Research has shown that the MyRisk Hereditary Cancer Test examines 48 genes linked to hereditary cancer risk. This test identifies genetic changes that may raise the likelihood of developing certain cancers. It is already used to assess cancer risk, indicating it is generally well-tolerated.

No negative effects have been reported from the test itself, as it only requires a blood or saliva sample. Since the test analyzes genetic information, it does not involve medication or procedures that might cause physical side effects. This makes it a low-risk option for those interested in understanding their hereditary cancer risk. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The MyRisk Hereditary Cancer Test is unique because it offers a comprehensive genetic analysis to identify hereditary cancer syndromes, which many current options do not specifically target. While traditional cancer screenings focus on detecting existing cancer, MyRisk aims to assess genetic risk factors that could lead to cancer, providing a proactive approach to cancer prevention. Researchers are excited about this because it could enable earlier interventions and personalized risk management, potentially reducing the likelihood of cancer development in high-risk individuals.

What evidence suggests that the MyRisk Hereditary Cancer Test is effective for cancer syndromes?

Research has shown that the MyRisk Hereditary Cancer Test, which participants in this trial will undergo, accurately identifies genetic changes linked to hereditary cancer risk. It boasts a 99.9% accuracy rate and rarely produces uncertain results for the BRCA1/2 genes, associated with breast and ovarian cancers. In a study with 2,000 patients, the test identified harmful mutations in 242 individuals. This demonstrates the test's effectiveness in spotting genetic cancer risks, aiding in early prevention. Early detection of these risks is crucial for managing health and preventing cancer. ^{1 2 3 5 6}

Who Is on the Research Team?

Melissa Frey, MD, MS

Principal Investigator

Weill Medical College of Cornell University

Are You a Good Fit for This Trial?

This trial is for pregnant individuals receiving routine prenatal care who are interested in learning about their inherited cancer risks. It aims to evaluate the acceptability and effectiveness of offering genetic testing for cancer risk during pregnancy.

Inclusion Criteria

I can speak and read in English or Spanish.

I chose to have my childbirth at a WCM-affiliated hospital.

Pregnant patients receiving obstetrical-related care at a WCM-affiliated enrollment site: WCM / NewYork-Presbyterian Hospital - Manhattan campus WCM / NewYork-Presbyterian Hospital - Lower Manhattan Hospital NewYork-Presbyterian Brooklyn Methodist Hospital NewYork-Presbyterian - Queens

Exclusion Criteria

I have a blood cancer or a condition that could turn into blood cancer.

I have had a bone marrow transplant using my own cells.

I have completed a genetic test for cancer risk.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Genetic Counseling and Testing

Participants receive genetic counseling and undergo combined hereditary cancer screening (HCS) and obstetric carrier screening (OCS)

Up to 18 months

Multiple visits as needed for counseling and testing

Follow-up

Participants are monitored for their experience and satisfaction with the genetic counseling and testing process

Up to 18 months post-screening

What Are the Treatments Tested in This Trial?

Interventions

• MyRisk Hereditary Cancer Test

Trial Overview The MyRisk Hereditary Cancer Test, which screens for BRCA1/2 genes among others, is being tested to see if it's a good fit alongside standard prenatal screening. The study will assess its impact on early cancer prevention and cost-effectiveness.

How Is the Trial Designed?

Group I: Collection of HCS and OCS Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Weill Medical College of Cornell University

Lead Sponsor

Trials

1,103

Recruited

1,157,000+

Myriad Genetics, Inc.

Industry Sponsor

Trials

18

Recruited

5,700+

Citations

1. myriad.com myriad.com/genetic-tests/myrisk-hereditary-cancer-risk-test/

MyRisk® Hereditary Cancer Test MyRisk Hereditary Cancer Test evaluates 48 genes associated with hereditary cancer risk to identify genetic changes in patients with a family history of ...

2. myriad.com myriad.com/getmyrisk/

MyRisk Hereditary Cancer Test With 99.9% accuracy, the MyRisk Test has one of the lowest rates of uncertain results for BRCA1/2 genes and updates your report as new discoveries are made.2,3 ...

3. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/gtr/tests/603556/

myRisk Hereditary Cancer - Clinical Genetic Test - GTR - NCBI Individuals at risk for a variety of hereditary cancer syndromes based on assessment of their personal and family cancer history. Variant Interpretation: What ...

4. s3.amazonaws.com s3.amazonaws.com/myriad-library/technical-specifications/myRisk+Hereditary+Cancer+Tech+Specs.pdf

myRisk+Hereditary+Cancer+Tech+Specs.pdf Test Results in which one or more genetic mutations have complex clinical interpretations that may or may not be related to cancer. Change ...

5. myriad.gcs-web.com myriad.gcs-web.com/news-releases/news-release-details/myriad-genetics-announces-results-large-2000-patient-clinical

Myriad Genetics Announces Results from a Large 2000 ... In total 2,000 patients were tested using the myRisk Hereditary Cancer test and 242 were found to have pathogenic mutations. The results showed ...

6. myriad.com myriad.com/hereditary-cancer-risk/patients/

Genetic testing for hereditary cancer risk For many patients, the MyRisk Test results also include RiskScore, a personalized 5-year and remaining lifetime risk estimate for developing breast cancer.