BRCA1/2-Associated Hereditary Breast and Ovarian Cancer SyndromeNCT06534424
Clinical Impact of Enhanced Risk Assessments in Women With a BRCA1/2 Mutation, CARE Study
A study testing Best Practice, Biospecimen Collection and Counseling in people with BRCA1/2-Associated Hereditary Breast and Ovarian Cancer Syndrome, run by Ohio State University Comprehensive Cancer Center at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- BRCA1/2-Associated Hereditary Breast and Ovarian Cancer Syndrome
- What is being tested?
- Best Practice, Biospecimen Collection and Counseling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jan 2018to 30 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have had genetic counseling and testing for mutations in BRCA1 and/or BRCA2 through a Clinical Laboratory Improvement Act (CLIA)-certified laboratory
- Were found to have a known pathogenic mutation upon testing
- Are within 3 weeks of results disclosure
- Have available medical records for ascertainment of clinical information
- Are able to provide a source of deoxyribonucleic acid (DNA) (blood or mouthwash) for study
- Have access to a telephone and a computer or other internet-ready device
- Have not yet had a bilateral prophylactic mastectomy or bilateral Salpingo oophorectomy
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, 84112
About this study
Official title: The caRe Study: Clinical Application of Refined Risk Estimates
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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.
- Being tested
- Best Practice, Biospecimen Collection, Counseling, Discussion, Genotyping
- Medical subject headings
- Hereditary Breast and Ovarian Cancer Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Best PracticeOther
Also called standard of care, standard therapy
Receive standard care
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection
Undergo collection of blood or mouthwash sample
CounselingOther
Also called Counseling Intervention
Receive tailored counseling
DiscussionProcedure or surgery
Also called Discuss
Participate in phone discussion
GenotypingProcedure or surgery
Also called GENOTYPE, Genotype Analysis, Genotype Assay
Undergo genotyping
Molecular Risk AssessmentProcedure or surgery
Undergo enhanced risk assessment
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I (enhanced risk assessment) | Experimental | 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. Receives: Procedure: Biospecimen Collection; Other: Counseling; Procedure: Discussion; Procedure: Genotyping; Procedure: Molecular Risk Assessment; Other: Questionnaire Administration |
| Arm II (standard) | Active comparator | Patients undergo collection of blood or mouthwash samples. 4-8 weeks later, patients receive a standard follow-up phone call. Receives: Other: Best Practice; Procedure: Biospecimen Collection; Procedure: Discussion; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2024
- Study start1 Jan 2018
- Primary completion30 Sep 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BRCA1/2-Associated Hereditary Breast and Ovarian Cancer SyndromeStudies of the same condition, open and under way.
- More trials run by Ohio State University Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amanda Toland, Ohio State University Comprehensive Cancer Center
- Investigators
- Amanda E Toland, Principal investigator, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06534424
- Sponsor's protocol ID
- OSU-17057
- Other IDs
- NCI-2022-07731
- Status last verified
- Jun 2025
- First submitted
- 30 Jul 2024
- Last updated
- 27 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The caRe Study: Clinical Application of Refined Risk Estimates
- ClinicalTrials.gov ID
- NCT06534424
- Acronym / sponsor ID
- OSU-17057
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 2 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVES:
- 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (enhanced risk assessment) | Experimental | Procedure: Biospecimen Collection, Other: Counseling, Procedure: Discussion, Procedure: Genotyping, Procedure: Molecular Risk Assessment, Other: Questionnaire AdministrationPatients 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. |
| Arm II (standard) | Active comparator | Other: Best Practice, Procedure: Biospecimen Collection, Procedure: Discussion, Other: Questionnaire AdministrationPatients undergo collection of blood or mouthwash samples. 4-8 weeks later, patients receive a standard follow-up phone call. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Have had genetic counseling and testing for mutations in BRCA1 and/or BRCA2 through a Clinical Laboratory Improvement Act (CLIA)-certified laboratory
- Were found to have a known pathogenic mutation upon testing
- Are within 3 weeks of results disclosure
- Have available medical records for ascertainment of clinical information
- Are able to provide a source of deoxyribonucleic acid (DNA) (blood or mouthwash) for study
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Best PracticeAlso: standard of care, standard therapyReceive standard care | Other | Arm II (standard) |
| Biospecimen CollectionAlso: Biological Sample Collection, Biospecimen Collected, Specimen CollectionUndergo collection of blood or mouthwash sample | Procedure or surgery | Arm I (enhanced risk assessment), Arm II (standard) |
| CounselingAlso: Counseling InterventionReceive tailored counseling | Other | Arm I (enhanced risk assessment) |
| DiscussionAlso: DiscussParticipate in phone discussion | Procedure or surgery | Arm I (enhanced risk assessment), Arm II (standard) |
| GenotypingAlso: GENOTYPE, Genotype Analysis, Genotype AssayUndergo genotyping | Procedure or surgery | Arm I (enhanced risk assessment) |
| Molecular Risk AssessmentUndergo enhanced risk assessment | Procedure or surgery | Arm I (enhanced risk assessment) |
| Questionnaire AdministrationAncillary studies | Other | Arm I (enhanced risk assessment), Arm II (standard) |
Primary outcome
Decisional conflict Regarding Cancer Risk Management
Time frame: Up to 3 months
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2025.
- The JameslineLink provided by the sponsor.
Related trials for BRCA1/2-Associated Hereditary Breast and Ovarian Cancer Syndrome
Recruiting
Identifying and Caring for Individuals With Inherited Cancer Syndrome
BRCA1/2-Associated Hereditary Breast and Ovarian Cancer Syndrome, Breast Ductal Carcinoma In Situ
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amanda E Toland principal investigator
Ohio State University Comprehensive Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Best Practice, Biospecimen Collection and Counseling in people with BRCA1/2-Associated Hereditary Breast and Ovarian Cancer Syndrome, run by Ohio State University Comprehensive Cancer Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decisional conflict Regarding Cancer Risk Management (time frame: Up to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2025.