An interventional study of Best Practice and Biospecimen Collection in BRCA1/2-Associated Hereditary Breast and Ovarian Cancer Syndrome, sponsored by Ohio State University Comprehensive Cancer Center. Completed at 2 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-27.
Sponsored by Ohio State University Comprehensive Cancer Center · Not applicable, Interventional, and Health services research
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 OBJECTIVES:
I. To deploy tools for delivering enhanced genetic risk predictions based on BRCA1/2 genetic risk modifiers in a clinical setting and assess the impact of risk stratification on genetic knowledge, risk perceptions and decisional conflict regarding cancer prevention decision-making.
II. To perform long-term follow-up of individuals in the randomized controlled trial (RCT) to determine if there are differences in satisfaction, decision-making and outcomes in individuals who received standard versus enhanced genetic risk predictions over time.
OUTLINE: Patients undergo collection of blood or mouthwash samples. Patients are then randomized to 1 of 2 arms.
ARM I: Patients undergo genotyping with enhanced risk assessment on study. 4 to 8 weeks later, patients receive a follow-up phone call for return of enhanced risk assessment results and tailored counseling.
ARM II: 4-8 weeks later, patients receive a standard follow-up phone call.
After completion of study intervention, patients are followed up for 2 years.
57 studies on the registry are indexed under Hereditary Breast and Ovarian Cancer Syndrome; 13 are open to participants now.
This study's enrollment of 152 is above the median of 121 across 40 interventional studies indexed under Hereditary Breast and Ovarian Cancer Syndrome.
Browse Hereditary Breast and Ovarian Cancer Syndrome studies →Ohio State University Comprehensive Cancer Center is the lead sponsor of 369 studies on the registry; 81 are open to participants now.
Of its 38 completed or terminated interventional studies of FDA-regulated products, 19 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Patients undergo collection of blood or mouthwash samples. Patients undergo genotyping with enhanced risk assessment on study. 4 to 8 weeks later, patients receive a follow-up phone call for return of enhanced risk assessment results and tailored counseling.
Procedure: Biospecimen Collection · Other: Counseling · Procedure: Discussion · Procedure: Genotyping · Procedure: Molecular Risk Assessment · Other: Questionnaire Administration
Patients undergo collection of blood or mouthwash samples. 4-8 weeks later, patients receive a standard follow-up phone call.
Other: Best Practice · Procedure: Biospecimen Collection · Procedure: Discussion · Other: Questionnaire Administration
Receive standard care
Also known as: standard of care, standard therapy
Undergo collection of blood or mouthwash sample
Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection
Receive tailored counseling
Also known as: Counseling Intervention
Participate in phone discussion
Also known as: Discuss
Undergo genotyping
Also known as: GENOTYPE, Genotype Analysis, Genotype Assay
Undergo enhanced risk assessment
Ancillary studies
Decisional conflict Regarding Cancer Risk Management
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.
Time frame: Up to 3 months
This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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Hereditary Breast and Ovarian Cancer Syndrome→
Ohio State University Comprehensive Cancer Center