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NCT04613440 · ClinicalTrials.gov registry record · NA
FaCT Trial (Facilitated Cascade Testing Trial)
A NA study of BRCA1 Mutation and BRCA2 Mutation, sponsored by Weill Medical College of Cornell University.
- Recruiting
- Registry status
- NA
- Development phase
- 820
- Enrollment target
- 3
- Study locations
NCT04613440: Recruiting NA study of BRCA1 Mutation and BRCA2 Mutation, sponsored by Weill Medical College of Cornell University.
NCT04613440 is a NA study of BRCA1 Mutation and BRCA2 Mutation that is actively recruiting participants, run by Weill Medical College of Cornell University. The registered enrollment target is 820 participants, above the 522-participant average among 15 other BRCA1 Mutation trials with a reported enrollment target (57% higher). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04613440, a NA study of BRCA1 Mutation and BRCA2 Mutation, is actively recruiting participants, sponsored by Weill Medical College of Cornell University.
- RECRUITING
- Registry status
- NA
- Development phase
- 820 participants
- Enrollment target
- 3
- Study locations
Study 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).
Primary Outcome
To compare proportion of completion of genetic testing at 6 months follow-up among first degree family relatives (referred to herein as "FDR": son, daughter, full-brother, full-sister, mother, father) of patients with a confirmed BRCA1/2 mutation (referred to as "proband") randomized to the intervention arm versus the standard of care.
Conditions Studied
Interventions
- OTHER Educational Video
- OTHER Family Letter (Standard of Care)
- OTHER Mailed Saliva Kit for Genetic Testing
- OTHER Telephone Counseling
Study Locations (3)
New York
- Weill Cornell Medicine - New York
North Carolina
- Duke University - Durham
Texas
- MD Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 820 participants |
| Start Date | 2021-07-21 |
| Est. Completion | 2026-12 |
| Phase | NA |
What NCT04613440 shows while recruiting
NCT04613440 is an interventional study that assigns participants to a tested intervention. The registered 820 participants enrollment target is mid-sized for trials with a published cap, above the 522-participant average among 15 other BRCA1 Mutation trials with a reported enrollment target (57% higher).
The record links to 2 conditions, with BRCA1 Mutation appearing as the primary indexed condition, and to 4 interventions - of which Educational Video is the first listed.
NCT04613440 reports a single indexed study location in New York, North Carolina, Texas.
Frequently Asked Questions
What is clinical trial NCT04613440 about?
NCT04613440 is a clinical study titled "FaCT Trial (Facilitated Cascade Testing Trial)". 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 agr...
What is the current status of trial NCT04613440?
This trial is currently recruiting. It is a NA study. The enrollment target is 820 participants. The study started on 2021-07-21. Estimated completion is 2026-12.
What conditions does trial NCT04613440 study?
This clinical trial studies the following conditions: BRCA1 Mutation, BRCA2 Mutation.
What interventions are being tested in trial NCT04613440?
The interventions under investigation include: Educational Video (OTHER), Family Letter (Standard of Care) (OTHER), Mailed Saliva Kit for Genetic Testing (OTHER), Telephone Counseling (OTHER).
Who is sponsoring clinical trial NCT04613440?
This trial is sponsored by Weill Medical College of Cornell University, which has 701 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04613440 being conducted?
This trial has 3 study locations across New York, North Carolina, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for BRCA1 Mutation
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04613440's enrollment target sits among peer trials
820 3rd of 15 higher than 13 of 15 other BRCA1 Mutation trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other BRCA1 Mutation trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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