Hereditary Cancer
Conditions
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.
Interventions
DIAGNOSTIC_TESTDiagnostic test
Genetic diagnostic test
Sponsors
Myriad Genetic Laboratories, Inc.
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 84 Years
Healthy volunteers
Yes
Inclusion criteria
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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| To derive a distribution of polygenic risk scores in an unselected patient population | baseline |
Countries
United States
Outcome results
None listed