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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

10000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-09-15

Study Completion Date

2027-04-30

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.

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Detailed Description

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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.

Conditions

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Breast Carcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Observational (mammography, questionnaires, blood 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.

Biospecimen Collection

Intervention Type PROCEDURE

Undergo collection of blood samples

Mammography

Intervention Type PROCEDURE

Undergo standard of care mammography

Questionnaire Administration

Intervention Type OTHER

Complete questionnaires

Interventions

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Biospecimen Collection

Undergo collection of blood samples

Intervention Type PROCEDURE

Mammography

Undergo standard of care mammography

Intervention Type PROCEDURE

Questionnaire Administration

Complete questionnaires

Intervention Type OTHER

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 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.

Minimum Eligible Age

25 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes