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Protocol for Postmenopausal Women at Increased Risk of Developing Breast Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Carol Fabian, MD, University of Kansas Medical Center Research Institute
ClinicalTrials.gov Identifier:
NCT00291083
First received: February 10, 2006
Last updated: February 6, 2012
Last verified: February 2012
History of Changes
  Purpose

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.


Condition
Breast Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Study of Manual Nipple Fluid Aspiration IN Post-Menopausal Women

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Kansas:

Enrollment: 229
Study Start Date: October 2005
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Medical center

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00291083

Locations
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
Carol Fabian, MD
Investigators
Principal Investigator: Carol J Fabian, MD University of Kansas
  More Information

No publications provided

Responsible Party: Carol Fabian, MD, Professor, Director Breast Cancer Prevention Unit, University of Kansas Medical Center Research Institute
ClinicalTrials.gov Identifier: NCT00291083     History of Changes
Other Study ID Numbers: 8427
Study First Received: February 10, 2006
Last Updated: February 6, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Kansas:
NAF
nipple aspirate fluid
breast atypia
high risk for breast cancer
 breast epithelial hyperplasia
Ki-67
hormones plus chemoprevention
chemoprevention

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on June 18, 2013