Breast Cancer Clinical Trial
Combined Breast Cancer Risk Study
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.
Full 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.
Eligibility Criteria
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
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There are 4 Locations for this study
Fayetteville Arkansas, 72703, United States
Boynton Beach Florida, 33437, United States
Hyannis Massachusetts, 02601, United States
Rochester New York, 14620, United States
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