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

Last updated: February 17, 2026
Sponsor: M.D. Anderson Cancer Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

Carcinoma

Cancer/tumors

Treatment

Mammography

Questionnaire Administration

Biospecimen Collection

Clinical Study ID

NCT03408353
PA17-0584
PA17-0584
NCI-2020-07361
  • Ages 25-80
  • Female
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

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 initialvisit and at follow up annual visits

  • Undergoing a screening mammogram at participating sites. Subjects undergoing routineannual diagnostic mammograms or CEM as part of a screening study are also eligible.

Exclusion

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] orinvasive breast cancer)

  • Personal history of any other cancer (excluding in-situ, stage 0, and non-melanomaskin cancers and other pre-cancerous conditions) treated within the last 5 years.

Study Design

Total Participants: 10000
Treatment Group(s): 3
Primary Treatment: Mammography
Phase:
Study Start date:
September 15, 2017
Estimated Completion Date:
April 30, 2027

Study 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.

Connect with a study center

  • M D Anderson Cancer Center

    Houston, Texas 77030
    United States

    Site Not Available

  • M D Anderson Cancer Center

    Houston 4699066, Texas 4736286 77030
    United States

    Active - Recruiting

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