Risk Assessments for Breast and Ovarian Cancer Syndrome

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

152 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Enhanced Risk Assessments for Breast and Ovarian Cancer Syndrome?

The effectiveness of Enhanced Risk Assessments for Breast and Ovarian Cancer Syndrome is supported by comprehensive programs that include genetic testing, counseling, and long-term follow-up for high-risk patients, as recommended by the Department of Defense Familial Breast/Ovarian Cancer Research Project. These programs help in identifying and managing patients at high risk, which can lead to better personalized care and potentially improved outcomes. ^{1 2 3 4 5}

Is the genetic cancer risk assessment for hereditary breast and ovarian cancer syndrome safe for humans?

The research articles provided do not contain specific safety data for the genetic cancer risk assessment for hereditary breast and ovarian cancer syndrome. ^{2 6 7 8 9}

How does the treatment Enhanced Risk Assessments differ from other treatments for breast and ovarian cancer syndrome?

Enhanced Risk Assessments focus on personalized risk prediction using models that consider genetic factors like BRCA mutations and family history, which is different from standard treatments that may not tailor prevention strategies as precisely. This approach helps in making informed decisions about preventive measures, such as the use of medications like Tamoxifen, based on individual risk profiles. ^{5 6 10 11 12}

What is the purpose of this trial?

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.

Research Team

Amanda E Toland

Principal Investigator

Ohio State University Comprehensive Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Guidelines for evaluation of patients at risk for inherited breast and ovarian cancer: recommendations of the Department of Defense Familial Breast/Ovarian Cancer Research Project. [2017]

2. England pubmed.ncbi.nlm.nih.gov

Genetic cancer risk assessment: A screenshot of the psychosocial profile of women at risk for hereditary breast and ovarian cancer syndrome. [2020]

3. England pubmed.ncbi.nlm.nih.gov

Improving referral for genetic risk assessment in ovarian cancer using an electronic medical record system. [2021]

4. France pubmed.ncbi.nlm.nih.gov

[Modalities for the functionning of a Care Center for women at high risk for breast and ovarian cancers: The French experience of Tenon Hospital]. [2010]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Breast cancer risks and risk prediction models. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Oral contraceptives and risk of ovarian cancer and breast cancer among high-risk women: a systematic review and meta-analysis. [2022]

7. New Zealand pubmed.ncbi.nlm.nih.gov

Patterns of referral and uptake of BReast CAncer (BRCA) gene testing of eligible women with ovarian cancer in New Zealand. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Cancer Risk Awareness and Concern among Women with a Family History of Breast or Ovarian Cancer. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Adherence to Recommended Risk Management among Unaffected Women with a BRCA Mutation. [2018]

10. England pubmed.ncbi.nlm.nih.gov

Proven non-carriers in BRCA families have an earlier age of onset of breast cancer. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Application of breast cancer risk prediction models in clinical practice. [2016]

12. England pubmed.ncbi.nlm.nih.gov

Identifying women with suspected ovarian cancer in primary care: derivation and validation of algorithm. [2021]