Mammography, Early Detection Biomarkers, Risk Assessment, and Imaging Technologies, MERIT Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Biospecimen Collection, Mammography, Questionnaire Administration.
- Who it may be relevant to
- Registry conditions: Breast Carcinoma. Basic parameters: 25 years — 80 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
MERIT (Mammography, Early Detection Biomarkers, Risk Assessment, and Imaging Technologies) Cohort
Overview
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.
Interventions
- Procedure Biospecimen Collection
Undergo collection of blood samples - Procedure Mammography
Undergo standard of care mammography - Other Questionnaire Administration
Complete questionnaires
Primary outcome measures
- Creation of a repository of blood specimens and database of imaging, clinical data, health measurements, and questionnaire data [Time frame: 5 years]
Eligibility 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 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- M D Anderson Cancer Center — Houston
Identifiers
NCT: NCT03408353 · PA17-0584 · NCI-2020-07361 · PA17-0584