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

Recruiting

• Conditions: Breast Carcinoma
• Interventions: Procedure: Biospecimen Collection; Procedure: Mammography; Other: Questionnaire Administration

• Registration Number: NCT03408353
• Lead Sponsor: M.D. Anderson Cancer Center

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2017-09-15
• Study First Submitted: 2017-12-11
• Study First Submitted QC: 2018-01-22
• Study First Posted: 2018-01-24
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-24
• Last Update Posted: 2025-02-25
• Primary Completion: 2027-04-30
• Study Completion: 2027-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 10000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Observational (mammography, questionnaires, blood collection)	Mammography	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.
Observational (mammography, questionnaires, blood collection)	Biospecimen Collection	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.
Observational (mammography, questionnaires, blood collection)	Questionnaire Administration	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.

Primary Outcome Measures

Name	Time	Method
Creation of a repository of blood specimens and database of imaging, clinical data, health measurements, and questionnaire data	5 years

Trial Locations

Locations (1)

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States