Clinical trial NCT03408353: Mammography, Early Detection Biomarkers, Risk Assessment, and Imaging Technologies, MERIT Study
Official title: MERIT (Mammography, Early Detection Biomarkers, Risk Assessment, and Imaging Technologies) Cohort
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Carcinoma
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2018-01-24
Enrollment: 10000
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants receiving screening mammograms at MD Anderson site

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.

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.

Primary outcomes:
measure: Creation of a repository of blood specimens and database of imaging, clinical data, health measurements, and questionnaire data
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Jessica W Leung
role: PRINCIPAL_INVESTIGATOR
References: