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Facilitated Genetic Testing for BRCA Mutation

Led By Melissa Frey, MD
Research Sponsored by Weill Medical College of Cornell University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
BRCA1/2 mutation that is included on testing panel provided by the clinical genetic testing laboratory
18 years of age or older as documented in the medical record
Screening 3 weeks
Treatment Varies
Follow Up 18 months
Awards & highlights

Study Summary

This trial will compare the efficacy of a multicomponent facilitated intervention vs. standard care in terms of the overall proportion of first degree relatives who complete genetic testing for inherited gynecologic/breast cancer syndromes.

Who is the study for?
This trial is for English or Spanish-speaking adults over 18 with a recent BRCA1/2 mutation diagnosis at select medical centers. They must be receiving care related to the mutation and have at least one first-degree relative who could also be at risk. People without email access or unable to consent are excluded.Check my eligibility
What is being tested?
The FaCT Trial is testing whether a new approach (including an educational video, genetic testing kits mailed home, and telephone counseling) helps more relatives of patients get tested for BRCA mutations compared to just getting a family letter about it.See study design
What are the potential side effects?
Since this trial involves non-medical interventions like education and genetic testing, there are no direct side effects from medications. However, participants may experience stress or anxiety related to genetic test results.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
My cancer has a BRCA1 or BRCA2 mutation.
I am 18 years old or older.
I can speak and read either English or Spanish.


Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of genetic testing by 6 months among FDRs on each study arm
Secondary outcome measures
Proportion of first-degree relatives who subsequently engage in recommended risk-reducing behaviors by 18 months

Trial Design

3Treatment groups
Experimental Treatment
Group I: Standard of care - Proband-mediated cascade testingExperimental Treatment1 Intervention
Probands randomized to the standard of care group will be instructed to share a family letter (providing information on the familial mutation) with their FDRs and encourage FDRs to complete genetic testing.
Group II: Intervention - Facilitated cascade testingExperimental Treatment3 Interventions
In the intervention group, a patient navigator will provide facilitated support, including an initial genetic counseling call, an email with a link to an educational video, and, for individuals who are interested in completing testing - a link to create an account for a free saliva kit and a follow-up call to discuss the results and ensure participants are connected with their primary care provider or other clinician, as appropriate.
Group III: Exploratory ArmExperimental Treatment3 Interventions
Probands of Jewish heritage at WCM only who do not meet eligibility criteria for randomization to the intervention and control arms will be offered enrollment in a third arm, in which they will receive the intervention in addition to referral to a culturally sensitive support organization for additional guidance.

Find a Location

Who is running the clinical trial?

Weill Medical College of Cornell UniversityLead Sponsor
1,054 Previous Clinical Trials
1,315,649 Total Patients Enrolled
Basser Research Center for BRCAUNKNOWN
Melissa Frey, MDPrincipal InvestigatorWeill Medical College of Cornell University
1 Previous Clinical Trials
250 Total Patients Enrolled

Media Library

Facilitated Cascade Testing Trial Intervention Clinical Trial Eligibility Overview. Trial Name: NCT04613440 — N/A
BRCA1 Research Study Groups: Exploratory Arm, Intervention - Facilitated cascade testing, Standard of care - Proband-mediated cascade testing
BRCA1 Clinical Trial 2023: Facilitated Cascade Testing Trial Intervention Highlights & Side Effects. Trial Name: NCT04613440 — N/A
Facilitated Cascade Testing Trial Intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT04613440 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacancies for volunteers in this clinical experiment?

"Affirmative. Per information hosted on clinicaltrials.gov, the trial is actively enrolling participants. This research was put up on July 21st 2021 and its latest update happened August 12th 2022; 600 subjects are needed from 3 distinct places of study."

Answered by AI

How many participants are currently involved in this research endeavor?

"Affirmative. Clinicaltrials.gov lists this medical trial as being actively recruiting, with the initial posting on July 21st 2021 and last edited on August 12th 2022. 600 patients need to be recruited from 3 different sites for this study."

Answered by AI
~55 spots leftby Aug 2024