NCT04613440 FaCT Trial (Facilitated Cascade Testing Trial)
| NCT ID | NCT04613440 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Weill Medical College of Cornell University |
| Condition | BRCA1 Mutation |
| Study Type | INTERVENTIONAL |
| Enrollment | 820 participants |
| Start Date | 2021-07-21 |
| Primary Completion | 2026-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 820 participants in total. It began in 2021-07-21 with a primary completion date of 2026-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this study is to assess an intervention that incorporates engagement strategies with a medical team navigator, an educational video and accessible genetic testing services to maximize the genetic testing and education of at-risk relatives. In this study, first degree relatives who agree to participate will either receive this intervention or standard of care. The investigators do not know if the facilitated interventional method will be more effective than the standard of care method. This research is being done because identification of patients with inherited gynecologic/breast cancer syndromes is critical to enable delivery of tailored cancer treatment and cancer prevention to both the patients and their at-risk relatives. Cascade genetic testing, defined as extending genetic testing to the family members of affected patients, results in a more precise risk assessment and initiation of appropriate cancer screening and prevention strategies. Therefore, this trial will compare the efficacy of a multicomponent facilitated intervention for first degree relatives vs. standard of care in terms of the overall proportion of first degree relatives who complete genetic testing by 6 months (primary outcome).
Eligibility Criteria
Inclusion Criteria: 1. 18 years of age or older as documented in the medical record 2. Speaks and reads English or Spanish as reported by the patient 3. Patients who are currently receiving diagnostic, treatment, or follow-up care at New York Presbyterian/ Weill Cornell Medical Center, MD Anderson Cancer Center, Duke University or Columbia University. 4. Patients with a newly diagnosed BRCA mutation presenting for consultation OR patients with known BRCA mutations who have been diagnosed with a confirmed deleterious (pathogenic) variant in BRCA1, or BRCA2 within the preceding 12 months as documented in the medical record 5. BRCA1/2 mutation that is included on testing panel provided by the clinical genetic testing laboratory 6. Patients who have at least one at risk relative who meets criteria for first degree relatives Exclusion Criteria: 1. Is unwilling or unable to provide informed consent. 2. Does not have email access.
Contact & Investigator
Melissa K Frey, MD, MS
PRINCIPAL INVESTIGATOR
Weill Medical College of Cornell University
Frequently Asked Questions
Who can join the NCT04613440 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying BRCA1 Mutation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04613440 currently recruiting?
Yes, NCT04613440 is actively recruiting participants. Contact the research team at mkf2002@med.cornell.edu for enrollment information.
Where is the NCT04613440 trial being conducted?
This trial is being conducted at New York, United States, Durham, United States, Houston, United States.
Who is sponsoring the NCT04613440 clinical trial?
NCT04613440 is sponsored by Weill Medical College of Cornell University. The principal investigator is Melissa K Frey, MD, MS at Weill Medical College of Cornell University. The trial plans to enroll 820 participants.