- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04474834
GENetic Risk Estimation of Breast Cancer Prior to Decisions on Preventive Therapy Uptake, Risk Reducing Surgery or Intensive Imaging Surveillance (GENRE2)
GENetic Risk Estimation of Breast Cancer Prior to Decisions on Preventive Therapy Uptake, Risk Reducing Surgery or Intensive Imaging Surveillance: A Study to Determine if a Polygenic Risk Score Influences the Decision Making Options Amongst High Risk Women (GENRE 2)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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Arizona
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Scottsdale, Arizona, United States, 85259
- Mayo Clinic
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Florida
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Jacksonville, Florida, United States, 32224-9980
- Mayo Clinic
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Illinois
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Evanston, Illinois, United States, 60208
- Northwestern University
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Minnesota
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Rochester, Minnesota, United States, 55905
- Mayo Clinic in Rochester
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Ohio
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Cleveland, Ohio, United States, 44195
- Cleveland Clinic
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Women > 35 years old and < 75 years old
Women with any of the following:
A. A NCI-BCRAT 5 year risk of ≥ 3% which corresponds to the level in which there is moderate evidence of treatment benefit outweighing risk according to the US Preventative Services Task Force (32); or B. IBIS (Tyrer-Cuzik) score for the 10 year risk of breast cancer of ≥8% 43 C. Biopsy proven atypical ductal hyperplasia or atypical lobular hyperplasia. D. History of lobular carcinoma in situ E. BRCA mutation carrier or other hereditary breast mutation carrier
- Able to participate in all aspects of the study
- Understand and signed the study informed consent
Exclusion Criteria:
- Women whose BCRAT falls below the threshold (<3 % 5 year risk) of moderate benefit according to the US Preventative Task Force AND Women whose IBIS score is <8% for the 10 year risk
- Women with known contra-indications to Tamoxifen, raloxifene ,exemestane, or anastrazole
- Current or prior use of Tamoxifen, raloxifene, exemestane or anastrazole
- Unable to give informed consent
- Prior history of invasive breast cancer, ductal carcinoma in situ or other breast cancers
- At high risk due to prior radiation therapy to the chest
- Women who are pregnant or breastfeeding
- Prior risk reducing or prophylactic mastectomy
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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PRS
Providing polygenic risk score (PRS)
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A Polygenic Risk Score (PRS) is a blood based genetic test which assesses 300 common breast cancer susceptibility loci (Single Nucleotide Polymorphisms).
The PRS has been retrospectively validated and categorizes women into three categories of lifetime risk of developing breast cancer: Low Risk (<15% lifetime risk), Above Average Risk (15 to 40%), and high risk (>40 %).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Patient self-reported intention to take a breast cancer preventing medication
Time Frame: up to 6 months after initial consultation
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up to 6 months after initial consultation
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Proportion of patients who are taking preventative medications each year for 10 years
Time Frame: Each year for up to 10 years
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Each year for up to 10 years
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Endocrine related quality of life scores each year for 10 years
Time Frame: Each year for up to 10 years
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Each year for up to 10 years
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Proportion of patient who are pursuing supplemental screening for 10 years
Time Frame: Each year for up to 10 years
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Each year for up to 10 years
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sandhya Pruthi, MD, Mayo Clinic
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 19-003085
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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