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

Study Overview
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Brief Summary
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This study collects mammogram images, blood samples, and clinical information from women undergoing routine screening mammograms. Creating a bank of blood samples and a database of clinical and risk information may be used in future research related to breast cancer, other cancers, and women's health.

Detailed Description
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PRIMARY OBJECTIVES: I. To establish a longitudinal cohort (n=10,000) of women who undergo 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.

Official Title
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MERIT (Mammography, Early Detection Biomarkers, Risk Assessment, and Imaging Technologies) Cohort

Conditions
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Breast Carcinoma

Intervention / Treatment
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* Procedure: Biospecimen Collection
* Procedure: Mammography
* Other: Questionnaire Administration


Participation Criteria
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Eligibility Criteria
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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 are also eligible at the MD Anderson site 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) Treatment of any other type of cancer within the past 5 years excluding in situ cervical and non-melanoma skin cancer

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Observational (mammography, questionnaires, blood collection)<br>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. | Procedure: Biospecimen Collection<br>* Undergo collection of blood samples<br>Procedure: Mammography<br>* Undergo standard of care mammography<br>Other: Questionnaire Administration<br>* Complete questionnaires<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Creation of a repository of blood specimens and database of imaging, clinical data, health measurements, and questionnaire data |  | 5 years |