Protocol for Postmenopausal Women at Increased Risk of Developing Breast Cancer

Breast Cancer Clinical Trial

Official title:

Study of Manual Nipple Fluid Aspiration IN Post-Menopausal Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00291083
• Other study ID #: 8427
• Status: Completed
• Phase: N/A
• First received: February 10, 2006
• Last updated: February 6, 2012
• Start date: October 2005
• Est. completion date: June 2008

Study information

• Verified date: February 2012
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Description:

To examine nipple aspirate fluid analysis in lactating women for local concentration of estrogen, prolactin, glucocorticoids, insulin, parity, prior lactation and age. NAF secretors have been reported to have modest increase in breast cancer risk compared to non-secretors . Estrogen levels have been found to be markedly higher in NAF samples than in the serum collected from the same women. Estradiol and estrone concentrations in premenopausal women are 10x and 20x greater in NAF samples than in serum and 50x and 35x greater in post-menopausal women not on HRT. It has been suggested that the disparity between serum and NAF levels may be due to local estrogen production via aromatase and sulfatase.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 229
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• women with high a high risk of breast cancer

• Older than 18

Exclusion Criteria:

• anticoagulants

• marked breast tenderness

• pregnant or within twelve months of breast feeding/childbirth

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Carol Fabian, MD

Country where clinical trial is conducted

United States,