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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03408353
Recruitment Status : Recruiting
First Posted : January 24, 2018
Last Update Posted : April 1, 2021
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Description
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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.

Condition or disease Intervention/treatment
Breast Carcinoma Procedure: Biospecimen Collection Procedure: Mammography Other: Questionnaire Administration

Detailed Description:

PRIMARY OBJECTIVES:

I. To establish a longitudinal cohort (n=10,000) of women who undergo 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 Design
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Study Type : Observational
Estimated Enrollment : 10000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: MERIT (Mammography, Early Detection Biomarkers, Risk Assessment, and Imaging Technologies) Cohort
Actual Study Start Date : September 15, 2017
Estimated Primary Completion Date : October 30, 2023
Estimated Study Completion Date : October 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mammography

Groups and Cohorts
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Group/Cohort Intervention/treatment
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.
 Procedure: Biospecimen Collection
Undergo collection of blood samples

Procedure: Mammography
Undergo standard of care mammography

Other: Questionnaire Administration
Complete questionnaires


Outcome Measures
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Primary Outcome Measures :
  1. Creation of a repository of blood specimens and database of imaging, clinical data, health measurements, and questionnaire data [ Time Frame: 5 years ]

Biospecimen Retention:   Samples With DNA
Blood

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Participants receiving screening mammograms at MD Anderson site
Criteria

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 are also eligible at the MD Anderson site

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)
  • Treatment of any other type of cancer within the past 5 years excluding in situ cervical and non-melanoma skin cancer
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03408353


Contacts
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Contact: Jessica Leung 713-745-4555 jwleung@mdanderson.org

Locations
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United States, Texas
M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Jessica W. Leung    713-745-4555    jwleung@mdanderson.org   
Principal Investigator: Jessica W. Leung         
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Jessica W Leung M.D. Anderson Cancer Center
More Information
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Additional Information:

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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT03408353    
Other Study ID Numbers: PA17-0584
NCI-2020-07361 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
PA17-0584 ( Other Identifier: M D Anderson Cancer Center )
First Posted: January 24, 2018    Key Record Dates
Last Update Posted: April 1, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases