Genetic Testing for Cancer Risk

Overseen By Sarah Lee

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: NYU Langone Health

Disqualifiers: Ovarian cancer, Germline testing, others

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

Compensation: Varies

Number of Visits: Unknown

600 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the feasibility of offering genetic testing for cancer risk during regular gynecology visits. It uses the Natera® Empower™ hereditary cancer panel to identify cancer-related genes and determine how many patients have these risk factors. Participants can choose to take the genetic test or opt out; those with concerning results can consult specialists about risk reduction and receive genetic counseling. Women receiving gynecologic care at certain NYU Langone Health sites, who have not had specific cancers or genetic tests, might be suitable candidates. As an unphased trial, this study provides participants the chance to contribute to research that could make genetic testing more accessible during routine healthcare visits.

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.

What prior data suggests that the Natera® Empower™ hereditary cancer panel test is safe?

Research has shown that the Natera® Empower™ hereditary cancer panel test checks for genes that may increase cancer risk. As a genetic test, not a medication or treatment, it is generally considered safe. The test requires a saliva sample, which is easy and painless to collect, with no known side effects.

This test examines DNA to identify gene changes that could raise the likelihood of developing cancer. It helps determine if cancer is prevalent in a family. The test does not cause physical harm, so there are no safety concerns. It is approved for identifying cancer risks, indicating it has been reviewed for safety as a genetic test. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Natera® Empower™ hereditary cancer panel test because it offers a proactive approach to identifying cancer risk through genetic testing. Unlike traditional methods that often focus on treating cancer after it develops, this panel test uses a saliva sample to pinpoint genetic markers that may indicate an increased risk of developing cancer. This allows for early intervention, as individuals with actionable genetic variants can pursue personalized risk-reduction strategies and receive specialized genetic counseling. This shift from reactive to preventative care is what makes this approach particularly promising.

What evidence suggests that the Natera® Empower™ hereditary cancer panel test is effective for genetic testing in gynecology patients?

Research has shown that the Natera® Empower™ hereditary cancer panel test effectively identifies individuals who might be at risk for certain cancers. One study found that about 2% of women tested carried a gene associated with hereditary cancer, aiding future medical decisions. This test examines many genes linked to cancer, helping to identify genetic risks that may be inherited. Participants in this trial who complete the genetic screening test can discuss their results with specialists and consider risk-reduction strategies. Understanding these risks enables individuals to manage their health proactively, such as through regular check-ups or preventive actions. The test assists individuals and their doctors in making informed health choices. ^{1 2 3 4 6}

Who Is on the Research Team?

Bhavana Pothuri, MD, MS

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

This trial is for patients visiting gynecology clinics who are interested in genetic testing to assess their cancer risk. It aims to determine if this testing can be done effectively without the need for specialized providers or meeting specific criteria.

Inclusion Criteria

Receive gynecologic care at an affiliated NYU Langone Health (NYULH) site listed in this protocol.

I am a woman aged between 25 and 39.

Exclusion Criteria

I have had ovarian, fallopian tube, peritoneal, or uterine cancer.

I have had both my ovaries and fallopian tubes surgically removed.

Visit related to pregnancy or immediately postpartum (within 2 weeks)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Genetic Testing

Participants undergo point-of-care genetic testing by saliva test

Up to 9 months

Follow-up

Participants are monitored for the presence of pathogenic variants and referred to specialists if necessary

Up to 9 months

What Are the Treatments Tested in This Trial?

Interventions

• Natera® Empower™ hereditary cancer panel test

Trial Overview The study is evaluating the Natera® Empower™ hereditary cancer panel test, which checks for genes related to cancer risk. Participants will also be referred to specialists if needed. The focus is on how many people get tested and how many have gene variants linked to cancer.

How Is the Trial Designed?

Group I: Completed genetic screening test Experimental Treatment 2 Interventions

Participants will complete point-of-care genetic testing by saliva test. Participants with actionable pathogenic variants will be referred to the appropriate specialists to discuss risk-reduction strategies and offered genetic counseling. All Participants will be given the opportunity for genetic counseling, and if interested and desired this will be facilitated by the research team.

Group II: Denied genetic screening test Active Control 1 Intervention

Participants in this arm have declined the genetic screening test.

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

Published Research Related to This Trial

Self-collected cervico-vaginal swabs showed a higher positivity rate for high-risk HPV (76%) compared to provider-collected samples (70%), indicating that self-collection could enhance cervical cancer screening coverage.

HPV-16 was the most prevalent genotype in both sample types and had the highest positive predictive value for detecting cervical intraepithelial neoplasia (CIN) grade 2 or higher, suggesting that while self-collection is effective, it may lead to increased referrals for colposcopy due to higher HPV-16 detection rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Extended HPV Genotyping to Compare HPV Type Distribution in Self- and Provider-Collected Samples for Cervical Cancer Screening. Rohner, E., Edelman, C., Sanusi, B., et al.[2021]

Citations

1. natera.com natera.com/resource-library/empower/

Empower Empower Gene Table - 81 Gene Panel Additional Cancer Risks 11 months ago ... Test (MRD) to Support More Patients Who Can Benefit from Hereditary Cancer Testing.

2. natera.com natera.com/oncology/empower-hereditary-cancer-test/

Hereditary Genetic Testing for Cancer – Empower Empower is a genetic test for those who want to know more about their risk of developing cancer, why it might be common in their family, or want to inform ...

3. natera.com natera.com/oncology/empower-hereditary-cancer-test/clinicians/

Empower Clinicians Empower is a genetic test for those who want to know more about their risk of developing cancer, why it might be common in their family, or want to inform ...

4. natera.com natera.com/oncology/empower-hereditary-cancer-test/patients/

Empower Patients Empower is a genetic test for those who want to know more about their risk of developing cancer, why it might be common in their family, or want to inform ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10787882/

Hereditary cancer testing in a diverse sample across three ... We found that 2% (39/1943) of women undergoing hereditary cancer gene testing as part of their clinical care at the time of breast imaging had ...

6. natera.com natera.com/oncology/empower-hereditary-cancer-test/faq/

Empower FAQ The Empower Hereditary Cancer Test helps you understand if you have increased risk for developing cancer or why it might be common in your family. This ...