Recruiting

Observational Study

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT03408353

Conditions

Breast Carcinoma

Eligibility Criteria

Sex: Female

Age: 25 - 70+

Healthy Volunteers: Accepted

Interventions

Biospecimen Collection

Mammography

Questionnaire Administration

Study Details

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.

Conditions

Breast Carcinoma

Study ID

NCT03408353

Start date

Sep 15, 2017

Status verified date

Aug, 2026

Completion date

Apr 30, 2027

Anticipated

Primary completion date

Apr 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 25 - 70+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

10000 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

Biospecimen Collection

Undergo collection of blood samples

Mammography

Undergo standard of care mammography

Questionnaire Administration

Complete questionnaires

Primary outcome measure

  • Creation of a repository of blood specimens and database of imaging, clinical data, health measurements, and questionnaire data [ Time Frame: 5 years ]

Central Contacts and Locations

Central contacts

Jessica Leung

713-745-4555jwleung@mdanderson.org

Locations

M D Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Jessica W. Leung

713-745-4555jwleung@mdanderson.org

Principal Investigator:

Jessica W. Leung

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

Aug 11, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2026-08-11.