Mammography, Early Detection Biomarkers, Risk Assessment, and Imaging Technologies, MERIT Study

PRIMARY OBJECTIVES:

I. To establish a longitudinal cohort (n=10,000) of women who undergo routine annual mammography screening with follow-up for at least five years for each study participant or until breast cancer diagnosis.

II. To create a repository of blood specimens from the cohort to use for biomarker discovery and validation.

III. To create a comprehensive integrated database of imaging, clinical data, health measurements, and questionnaire data on the study participants.

OUTLINE:

Participants complete questionnaires over 15-25 minutes about personal and family history of cancer, health status, breast cancer risk factors, diet, weight gain, and physical activity, and undergo collection of blood samples at baseline and then annually for 5 years. Participants also undergo standard of care mammography at baseline and then annually for 5 years.

Inclusion criteria

• Willingness to participate in the study and ability to provide informed consent
• Willingness to complete a questionnaire and to provide a blood sample at the initial visit and at follow up annual visits
• Undergoing a screening mammogram at participating sites. Subjects undergoing routine annual diagnostic mammograms or CEM as part of a screening study are also eligible.

Exclusion criteria

• Current or recent (within the prior 6 months) history of breast feeding
• Personal history of breast cancer (ductal breast carcinoma in situ [DCIS] or invasive breast cancer)
• Personal history of any other cancer (excluding in-situ, stage 0, and non-melanoma skin cancers and other pre-cancerous conditions) treated within the last 5 years.