Risk Assessments for Breast and Ovarian Cancer Syndrome

No longer recruiting at 1 trial location

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Ohio State University Comprehensive Cancer Center

Disqualifiers: Bilateral mastectomy, Salpingo-oophorectomy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 4-8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a more personalized approach to understanding cancer risk can help women with a BRCA1 or BRCA2 mutation make better health decisions. Women with these mutations face a higher risk of developing breast and ovarian cancer. The study examines if enhanced risk assessments (a more detailed evaluation of cancer risk) can improve their comfort and knowledge about prevention options. Participants will receive either standard or enhanced risk assessments and counseling. Women who recently learned of their BRCA1 or BRCA2 mutation and have not yet undergone preventive surgeries might be suitable for this trial. As an unphased trial, this study offers a unique opportunity to contribute to research on personalized cancer risk assessment.

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What prior data suggests that enhanced risk assessments are safe for patients with BRCA1/2 mutations?

Research has shown that enhanced risk assessments for breast and ovarian cancer are generally well-received by patients. These assessments gather personal and family history to identify individuals at higher risk of developing cancer. No reports indicate physical harm from the assessment itself. Instead, the process aims to provide more accurate risk predictions, helping patients make better-informed health care decisions.

The main goal of these assessments is to improve understanding and decision-making without adding any risks. While the assessment is non-invasive, participants must feel comfortable with the information and guidance they receive. Overall, enhanced risk assessments have proven to be a safe tool in cancer prevention strategies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the enhanced risk assessments for breast and ovarian cancer syndrome because they offer a more personalized approach to understanding individual risk. Unlike traditional methods that rely on standard data, this enhanced assessment uses genotyping to provide a deeper insight into a person’s genetic predispositions. This means patients receive tailored counseling and more precise information about their cancer risk, potentially leading to better prevention and early detection strategies.

What evidence suggests that enhanced risk assessments are effective for improving decision-making in women with BRCA1/2 mutations?

This trial will compare enhanced risk assessments with standard assessments for women with BRCA1 or BRCA2 gene changes. Studies have shown that improved risk assessments help women make more informed decisions about cancer prevention. These assessments offer personalized information about cancer risk based on genetic tests and family history. Research indicates that this method helps women better understand their risks and reduces uncertainty about prevention options. For instance, guidelines often recommend more frequent check-ups or preventative surgeries for those at high risk. By customizing the risk assessment, women may feel more confident and comfortable with their cancer prevention choices. ^{1 2 4 6 7}

Who Is on the Research Team?

Amanda E Toland

Principal Investigator

Ohio State University Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for women with a BRCA1 or BRCA2 mutation, which greatly increases their risk of breast and ovarian cancer. It aims to see if personalized risk assessments affect their understanding and decisions about cancer prevention.

Inclusion Criteria

My tests showed a known harmful genetic change.

Are within 3 weeks of results disclosure

Have available medical records for ascertainment of clinical information

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo genotyping with enhanced risk assessment and receive tailored counseling

4-8 weeks

1 visit (in-person), 1 follow-up call

Follow-up

Participants are monitored for satisfaction, decision-making, and outcomes after receiving risk assessments

2 years

What Are the Treatments Tested in This Trial?

Interventions

• Enhanced Risk Assessments

Trial Overview The study tests whether enhanced risk assessments (including discussions, molecular risk assessment, genotyping) influence knowledge and decision-making in women at high genetic risk for breast and ovarian cancers.

How Is the Trial Designed?

Group I: Arm I (enhanced risk assessment) Experimental Treatment 6 Interventions

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.

Group II: Arm II (standard) Active Control 4 Interventions

Patients undergo collection of blood or mouthwash samples. 4-8 weeks later, patients receive a standard follow-up phone call.

Who Is Running the Clinical Trial?

Ohio State University Comprehensive Cancer Center

Lead Sponsor

Trials

350

Recruited

295,000+

Published Research Related to This Trial

Breast cancer risk assessment helps estimate the likelihood of developing the disease and can identify specific genetic risks, such as BRCA1 or BRCA2 mutations, which is crucial for guiding management strategies.

Recent advancements in risk assessment have led to effective prevention options like Tamoxifen chemoprevention and tailored management for mutation carriers, emphasizing the need for a combination of models and clinical judgment for accurate counseling.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Application of breast cancer risk prediction models in clinical practice. Domchek, SM., Eisen, A., Calzone, K., et al.[2016]

BRCA1 mutation carriers have a breast cancer risk of 40-87% and ovarian cancer risk of 22-65%, while BRCA2 carriers have a breast cancer risk of 18-88% and ovarian cancer risk of 10-35%, highlighting the significant cancer risk associated with these mutations.

Risk prediction models that incorporate family history and genetic factors are essential for personalized risk assessment and clinical management of BRCA mutation carriers, but further validation through prospective studies is necessary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Breast cancer risks and risk prediction models. Engel, C., Fischer, C.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3521596/

Outcomes of a Systems-Level Intervention Offering Breast ... A systems-level intervention designed to systematically collect information about personal and family cancer history, identify women who may be at risk for HBOC ...

2. annalsofoncology.org annalsofoncology.org/article/S0923-7534(22)04193-X/fulltext

Risk reduction and screening of cancer in hereditary breast ... It provides recommendations for risk reduction and screening in hereditary breast and ovarian cancer syndrome.

3. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2815069

Cost-Effectiveness of Multigene Testing for Breast and ... Population-based testing was a more cost-effective strategy for the prevention of breast cancer and ovarian cancer when compared with the current family ...

4. acog.org acog.org/clinical/clinical-guidance/practice-bulletin/articles/2017/07/breast-cancer-risk-assessment-and-screening-in-average-risk-women

Breast Cancer Risk Assessment and Screening in Average ... The purpose of this Practice Bulletin is to discuss breast cancer risk assessment, review breast cancer screening guidelines in average-risk women,

5. nature.com nature.com/articles/s41416-023-02145-w

Proactive breast cancer risk assessment in primary care In this article, we review the literature surrounding proactive breast cancer risk assessment within primary care against the consolidated framework for ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05810025?tab=table

FHIR-Enhanced RealRisks to Improve Accuracy of Breast ... The purpose of this study is to assess how the integration of patient generated health data (PGHD) and EHR data can generate more accurate risk prediction ...

7. aacrjournals.org aacrjournals.org/cancerpreventionresearch/article/14/2/205/47398/Assessment-of-and-Interventions-for-Women-at-High

Assessment of and Interventions for Women at High Risk for ... The objective of this study is to assess use, familiarity, attitude, and behaviors of PCPs regarding breast and ovarian cancer risk and prevention.