Hereditary Cancer Screening for Cancer Syndromes

(FOCUS Trial)

Overseen By Reena Vattakalam

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Columbia 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: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the benefits and acceptability of offering genetic testing for cancer risks to individuals receiving prenatal or preconception care. It aims to determine if this testing, alongside routine prenatal genetic screenings, aids in early cancer prevention. The trial includes two groups: one receives both hereditary cancer testing (using the Natera empower comprehensive hereditary cancer panel) and the usual prenatal screening, while the other receives only the standard prenatal screening. It is suitable for those receiving obstetrical care at specific sites, particularly if they can read and speak English or Spanish. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research in integrating cancer risk testing with prenatal care.

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 this screening method is safe?

Research shows that the Natera Empower Comprehensive Hereditary Cancer Panel is a genetic test used to assess cancer risks. This non-invasive test does not require surgery or tools entering the body. It is generally safe, using a simple sample, such as saliva or blood, to identify genes linked to cancer risk. No reports of harmful side effects have emerged from this type of testing.

Genetic tests like this one are usually easy for individuals to manage. They often aid in understanding health risks and making informed decisions. For those considering a trial that includes this test, its safety record is reassuring based on its use in other contexts. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Natera empower comprehensive hereditary cancer panel because it offers a more thorough approach to hereditary cancer screening compared to existing options. Unlike traditional screenings that might focus on a narrower set of genetic markers, this panel provides a comprehensive look at multiple potential cancer syndromes, offering a broader assessment. This expansive scope can help identify at-risk individuals more accurately, potentially leading to earlier interventions and more personalized care strategies.

What evidence suggests that this trial's treatments could be effective for hereditary cancer screening?

This trial will compare two approaches: Arm A, where participants undergo hereditary cancer testing using the Natera empower comprehensive hereditary cancer panel, and Arm B, where participants do not receive hereditary cancer testing. Research has shown that the Natera empower comprehensive hereditary cancer panel reliably identifies cancer risks based on genetics. This test informs individuals about their chances of developing certain types of cancer, particularly if these cancers are familial. Studies indicate that hereditary cancer testing can identify individuals who should undergo further tests, such as those assessing breast and ovarian cancer risks. Early identification of these risks is crucial for cancer prevention. By understanding their genetic risks, individuals can make informed decisions about their health and cancer prevention strategies. ^{1 2 3 4 6}

Who Is on the Research Team?

Shayan Dioun, MD

Principal Investigator

Columbia University

Are You a Good Fit for This Trial?

This trial is for individuals receiving routine prenatal care or preconception care. It's designed to see if adding hereditary cancer risk screening during this time is something patients are interested in and find acceptable.

Inclusion Criteria

Patients receiving obstetrical-related care at a CUMC-affiliated enrollment site

I am between 18 and 55 years old.

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

Exclusion Criteria

I have completed a genetic test for cancer risk.

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Counseling and Testing

Participants receive counseling on potential risks and benefits of genetic testing and undergo obstetrical carrier screening (OCS) and hereditary cancer screening (HCS) if they choose to participate.

4-8 weeks

1 visit (in-person) for blood draw and counseling

Survey and Interview

Participants complete surveys to evaluate acceptance of testing and experience, and may participate in interviews conducted by trained qualitative experts.

2-6 months

Surveys and interviews conducted virtually

Follow-up

Participants who completed HCS and had a mutation that resulted in a recommendation for clinical follow-up will be contacted to assess completion of medical follow-up.

18 months

Contact by telephone

What Are the Treatments Tested in This Trial?

Interventions

• Natera empower comprehensive hereditary cancer panel
• Obstetrical carrier screening

Trial Overview The study tests the feasibility of combining standard obstetrical carrier screening with a comprehensive hereditary cancer panel called Natera Empower. The aim is to assess whether offering these screenings together can aid early cancer prevention.

How Is the Trial Designed?

Group I: Arm A: Hereditary cancer testing Experimental Treatment 2 Interventions

Hereditary Cancer screenings testing and Obstetric Cancer Screening

Group II: Arm B: No hereditary caner testing Active Control 1 Intervention

Obstetric Cancer screening test only

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials

1,529

Recruited

2,832,000+

Natera, Inc.

Industry Sponsor

Trials

56

Recruited

50,700+

Citations

1. 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 ...

2. 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 ...

3. 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 ...

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

Empower View Patient Results on NateraConnect · Contact Us. Patient ResourcesPatient ... Performance of the Empower Comprehensive Hereditary Cancer Test. Read More.

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

Hereditary cancer testing in a diverse sample across three ... Overall, 18.2% (354/1943) of patients met current NCCN guidelines for hereditary breast and ovarian cancer (HBOC) gene testing, 3.7% (71/1943) ...

6. natera.com natera.com/resource-library/

Resource Library Performance of the Empower Comprehensive Hereditary Cancer Test about 1 year ago. Performance of the Empower Comprehensive Hereditary Cancer Test. Read More.