NCT00291083

Brief Summary

To examine nipple aspirate fluid for secretions that may be identified as a high risk indicator for development of breast cancer, and compare those to serum analysis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
229

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2005

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

October 1, 2005

Completed
4 months 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
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
Last Updated

February 7, 2012

Status Verified

February 1, 2012

Enrollment Period

2.7 years

First QC Date

February 10, 2006

Last Update Submit

February 6, 2012

Conditions

Breast Cancer

Keywords

NAFnipple aspirate fluidbreast atypiahigh risk for breast cancerbreast epithelial hyperplasiaKi-67hormones plus chemopreventionchemoprevention

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Medical center

You may qualify if:

  • women with high a high risk of breast cancer
  • Older than 18

You may not qualify if:

  • anticoagulants
  • marked breast tenderness
  • pregnant or within twelve months of breast feeding/childbirth

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

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

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor, Director Breast Cancer Prevention Unit

Study Record Dates

First Submitted

February 10, 2006

First Posted

February 13, 2006

Study Start

October 1, 2005

Primary Completion

June 1, 2008

Study Completion

June 1, 2008

Last Updated

February 7, 2012

Record last verified: 2012-02

Locations

US(1)