NCT03408353

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10,000

participants targeted

Target at P75+ for all trials

Timeline
12mo left

Started Sep 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress90%
Sep 2017Apr 2027

Study Start

First participant enrolled

September 15, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 11, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 24, 2018

Completed
9.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2027

Last Updated

February 19, 2026

Status Verified

February 1, 2026

Enrollment Period

9.6 years

First QC Date

December 11, 2017

Last Update Submit

February 17, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Creation of a repository of blood specimens and database of imaging, clinical data, health measurements, and questionnaire data

    5 years

Study Arms (1)

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 CollectionProcedure: MammographyOther: Questionnaire Administration

Interventions

Undergo collection of blood samples

Observational (mammography, questionnaires, blood collection)
MammographyPROCEDURE

Undergo standard of care mammography

Observational (mammography, questionnaires, blood collection)

Complete questionnaires

Observational (mammography, questionnaires, blood collection)

Eligibility Criteria

Age25 Years - 80 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants receiving screening mammograms at MD Anderson site

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Blood

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Jessica W Leung

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 11, 2017

First Posted

January 24, 2018

Study Start

September 15, 2017

Primary Completion (Estimated)

April 30, 2027

Study Completion (Estimated)

April 30, 2027

Last Updated

February 19, 2026

Record last verified: 2026-02

Locations