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NCT06534424 · ClinicalTrials.gov registry record · NA
Clinical Impact of Enhanced Risk Assessments in Women With a BRCA1/2 Mutation, CARE Study
A NA study of BRCA1/2-Associated Hereditary Breast and Ovarian Cancer Syndrome, sponsored by Ohio State University Comprehensive Cancer Center.
- Completed
- Registry status
- NA
- Development phase
- 152
- Enrollment target
- 2
- Study locations
NCT06534424: Completed NA study of BRCA1/2-Associated Hereditary Breast and Ovarian Cancer Syndrome, sponsored by Ohio State University Comprehensive Cancer Center.
NCT06534424 is a NA study of BRCA1/2-Associated Hereditary Breast and Ovarian Cancer Syndrome that has completed, run by Ohio State University Comprehensive Cancer Center. The registered enrollment target is 152 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (89% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06534424, a NA study of BRCA1/2-Associated Hereditary Breast and Ovarian Cancer Syndrome, has completed, sponsored by Ohio State University Comprehensive Cancer Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 152 participants
- Enrollment target
- 2
- Study locations
Study Summary
This clinical trial evaluates the impact of enhanced risk assessments on knowledge, perceptions, and decisional conflict about cancer prevention in women with a BRCA1 or BRCA2 mutation. BRCA1/2 mutation carriers have a much higher risk of developing breast and ovarian cancer. Due to the high risk of cancer, mutation carriers are provided guidelines on more intensive screening and preventative surgeries such as bilateral mastectomy and bilateral salpingo-oophorectomy. Doctors want to learn if a more personalized risk assessment impacts the patients' risk perceptions and comfort with decision-making around cancer prevention behaviors.
Primary Outcome
Decisional conflict regarding cancer risk management will be measured via a questionnaire. Comparison of this measure between the enhanced and standard arms adjusting for stratified randomization will be made using linear regression. The alpha level for the outcome will be 0.05.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- OTHER Best Practice
- OTHER Counseling
- PROCEDURE Discussion
- PROCEDURE Genotyping
Study Locations (2)
Ohio
- Ohio State University Comprehensive Cancer Center - Columbus
Utah
- Huntsman Cancer Institute/University of Utah - Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 152 participants |
| Start Date | 2018-01-01 |
| Est. Completion | 2023-09-30 |
| Phase | NA |
What the finished NCT06534424 record still lists
NCT06534424 is an interventional study that assigns participants to a tested intervention. The registered 152 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (89% lower).
The record links to 1 condition, with BRCA1/2-Associated Hereditary Breast and Ovarian Cancer Syndrome appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT06534424 reports a single indexed study location in Ohio, Utah.
Frequently Asked Questions
What is clinical trial NCT06534424 about?
NCT06534424 is a clinical study titled "Clinical Impact of Enhanced Risk Assessments in Women With a BRCA1/2 Mutation, CARE Study". This clinical trial evaluates the impact of enhanced risk assessments on knowledge, perceptions, and decisional conflict about cancer prevention in women with a BRCA1 or BRCA2 mutation. BRCA1/2 mutation carriers have a much higher risk of developing breast and ovarian cancer. Due to the high risk of...
What is the current status of trial NCT06534424?
This trial is currently completed. It is a NA study. The enrollment target is 152 participants. The study started on 2018-01-01. Estimated completion is 2023-09-30.
What conditions does trial NCT06534424 study?
This clinical trial studies the following conditions: BRCA1/2-Associated Hereditary Breast and Ovarian Cancer Syndrome.
What interventions are being tested in trial NCT06534424?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Best Practice (OTHER), Counseling (OTHER), Discussion (PROCEDURE), Genotyping (PROCEDURE).
Who is sponsoring clinical trial NCT06534424?
This trial is sponsored by Ohio State University Comprehensive Cancer Center, which has 341 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06534424 being conducted?
This trial has 2 study locations across Ohio, Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06534424's enrollment target sits among peer trials
152 658th of 2000 higher than 1,340 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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