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FaCT Trial (Facilitated Cascade Testing Trial)
NCT04613440 · View on ClinicalTrials.gov ↗
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04613440
The ClinicalTrials.gov registry entry for NCT04613440 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 820 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Weill Medical College of Cornell University, which has 679 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04613440 reports 3 study locations spanning 3 distinct geographic areas — top geographies include New York, North Carolina, Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04613440?
This trial is sponsored by Weill Medical College of Cornell University, which has 679 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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