NCT00291096

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
3,000

participants targeted

Target at P75+ for all trials

Timeline
19mo left

Started Aug 1989

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 Progress96%
Aug 1989Dec 2027

Study Start

First participant enrolled

August 1, 1989

Completed
16.5 years until next milestone

First Submitted

Initial submission to the registry

February 10, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 13, 2006

Completed
21.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

October 29, 2025

Status Verified

October 1, 2025

Enrollment Period

38.4 years

First QC Date

February 10, 2006

Last Update Submit

October 27, 2025

Conditions

Breast Cancer

Keywords

breast atypiafine needle aspirationhigh risk for breast cancerbreast epithelial hyperplasia

Outcome Measures

Primary Outcomes (1)

  • Prediction of risk for developing breast cancer

    development of algorithm for predicting risk for developing breast cancer based on random sampling of benign breast tissue.

    ongoing

Eligibility Criteria

Age30 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Self-identified women at high risk for development of breast cancer

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

RPFNA specimens, serum, NAF

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Carol J Fabian, MD

    University of Kansas Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Bruce Kimler, Ph.D.

CONTACT

913-588-4523bkimler@kumc.edu

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 10, 2006

First Posted

February 13, 2006

Study Start

August 1, 1989

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

October 29, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)