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

M.D. Anderson Cancer Center

Status

Enrolling

Conditions

Breast Carcinoma

Treatments

Procedure: Mammography

Other: Questionnaire Administration

Procedure: Biospecimen Collection

Study type

Observational

Funder types

Other

NIH

Identifiers

NCT03408353

NCI-2020-07361 (Registry Identifier)

PA17-0584 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment

10,000 estimated patients

Sex

Female

Ages

25 to 80 years old

Volunteers

Accepts Healthy Volunteers

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.