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

Breast Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03408353
• Other study ID #: PA17-0584
• Secondary ID: NCI-2020-07361PA
• Status: Recruiting
• Start date: September 15, 2017
• Est. completion date: April 30, 2025

Study information

• Verified date: February 2024
• Source: M.D. Anderson Cancer Center
• Contact: Jessica Leung
• Phone: 713-745-4555
• Email: jwleung[@]mdanderson.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. completion date: April 30, 2025
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Carcinoma
• Breast Neoplasms

Intervention

Procedure:
• Biospecimen Collection
Undergo collection of blood samples
• Mammography
Undergo standard of care mammography

Other:
• Questionnaire Administration
Complete questionnaires

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Creation of a repository of blood specimens and database of imaging, clinical data, health measurements, and questionnaire data		5 years

External Links

•   The University of Texas MD Anderson Cancer Center Official Website