Recruiting

Observational Study

Sponsor:

Carol Fabian, MD

Code:

NCT00291096

Conditions

Breast Cancer

Eligibility Criteria

Sex: Female

Age: 30 - 65

Healthy Volunteers: Accepted

Study Details

Brief summary:

The overall goal of this project is to develop an integrative system of breast cancer risk assessment based on epidemiologic and biologic risk variables, as well as to develop or refine risk biomarkers which may be useful in predicting and monitoring response to prevention interventions.

Conditions

Breast Cancer

Study ID

NCT00291096

Start date

Aug, 1989

Status verified date

Oct, 2025

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 30 - 65

Healthy Volunteers: Accepted

Inclusion Criteria:

  • women with at least 2 times the normal risk of developing breast cancer
  • between the ages of 30-65 (or within 10 years of youngest age at diagnosis in first degree relative)
  • greater than six months from ingestion of antihormonal therapy
  • greater than 1 year from pregnancy, lactation, or chemotherapy
  • willing to have a mammogram within six months prior to RPFNA
  • willing to discontinue NSAIDS or herbal supplements
  • willing to have blood drawn

Exclusion Criteria:

  • no metastatic malignancy of any kind
  • no breast implants or tram flap reconstructions
  • no radiation to both breasts
  • no women who have a current mammogram or clinical breast exam suspicious for cancer

Study Design

Enrollment

3000 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Prediction of risk for developing breast cancer [ Time Frame: ongoing ]

Central Contacts and Locations

Central contacts

Bruce Kimler, Ph.D.

913-588-4523bkimler@kumc.edu

Locations

University of Kansas Medical Center

Recruiting

Kansas City, Kansas, United States, 66160

Principal Investigator:

Carol J Fabian, MD

More Information

Sponsor

Carol Fabian, MD

Last update posted

Oct 29, 2025

Last verified

Oct, 2025

Keywords

  • breast atypia
  • fine needle aspiration
  • high risk for breast cancer
  • breast epithelial hyperplasia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Carol Fabian, MD on 2025-10-29.