Combined Breast Cancer Risk Study
- Conditions
- Hereditary Cancer
- Interventions
- Diagnostic Test: Diagnostic test
- Registration Number
- NCT03067389
- Lead Sponsor
- Myriad Genetic Laboratories, Inc.
- Brief Summary
A prospective, non-interventional study in women 18 to 84 years of age. Subjects will provide a sample for genetic testing and information about their medical and family history. The results of the genetic test will be combined with clinical data to validate a method of predicting breast cancer risk.
- Detailed Description
This is a prospective, non- interventional study. Women presenting at imaging centers for routine breast cancer screening or breast cancer diagnostic assessment and who provide written informed consent will undergo genetic testing. Subjects will also provide information about their personal medical and cancer history and family cancer history. The results of the genetic test will be combined with the subject's clinical information, family history, and a risk assessment model to validate a new method of predicting breast cancer.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 553
Women without breast cancer:
- 18 to 84 years of age
- Western/Northern European, Central/Eastern European, or Ashkenazi ancestry
- No history of invasive breast cancer
Women with a history of breast cancer:
- 18 to 84 years of age
- Western/Northern European, Central/Eastern European, or Ashkenazi ancestry
- Pathologically confirmed invasive breast cancer diagnosed within the past 12 months
- Unwilling to provide written informed consent
- Women with history of ductal carcinoma in situ (DCIS).
- Patient has had a prior breast biopsy, exclusive of a breast biopsy diagnostic of breast cancer, that showed either hyperplasia, atypical hyperplasia, lobular carcinoma in situ (LCIS), or the specific histologic result is unknown to the patient
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description History of invasive breast cancer Diagnostic test Subjects with a diagnosis of invasive breast cancer within the past 12 months will provide a blood or saliva sample for genetic diagnostic testing and provide information about their personal medical and cancer history and family cancer history. No history of invasive breast cancer Diagnostic test Subjects with no history of breast cancer will provide a blood or saliva sample for genetic diagnostic testing and provide information about their personal medical and cancer history and family cancer history.
- Primary Outcome Measures
Name Time Method To demonstrate that a combined breast cancer risk derived from a polygenic risk score and a breast cancer risk assessment model is a better predictor of breast cancer than the risk assessment model alone Baseline
- Secondary Outcome Measures
Name Time Method To derive a distribution of polygenic risk scores in an unselected patient population baseline
Trial Locations
- Locations (4)
The Breast Center of Northwest Arkansas
🇺🇸Fayetteville, Arkansas, United States
Cuda Women's Health Center
🇺🇸Hyannis, Massachusetts, United States
Elizabeth Wende Breast Care
🇺🇸Rochester, New York, United States
Bethesda Health
🇺🇸Boynton Beach, Florida, United States