Protocol for Postmenopausal Women at Increased Risk of Developing Breast Cancer

This study is currently recruiting participants.

Verified by University of Kansas, August 2009

First Received: May 19, 2006 Last Updated: August 20, 2009 History of Changes

Sponsors and Collaborators:	University of Kansas Intergenetics, Inc.
Information provided by:	University of Kansas
ClinicalTrials.gov Identifier:	NCT00329017

Purpose

A study to examine the potential associations between common single nucleotide polymorphisms and pre-cancerous conditions in breast tissue specimens from postmenopausal women.

Condition	Intervention
Breast Cancer	Procedure: Fine needle aspiration

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Correlation of SNP Patterns With Fine Needle Aspiration Cytomorphology in High Risk Postmenopausal Women

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

U.S. FDA Resources

Further study details as provided by University of Kansas:

Biospecimen Retention: Samples With DNA

Biospecimen Description:

Fine needle aspirate

Estimated Enrollment:	500
Study Start Date:	May 2005
Estimated Study Completion Date:	May 2010
Estimated Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
1 Post-menopausal women who are at increased risk for development of breast cancer on the basis of family or personal history.	Procedure: Fine needle aspiration Fine needle aspiration

Detailed Description:

A study to examine the correlation between single nucleotide polymorphisms (SNPs) affecting steroid and carcinogen metabolism and benign breast tissue cytomorphology collected via random periareolar fine needle aspiration in postmenopausal women at increased risk for breast cancer and taking hormone replacement therapy.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Post menopausal women, on or off hormone replacement therapy, at high risk of developing breast cancer

Criteria

Inclusion Criteria:

postmenopausal women on or off hormone replacement therapy
at high risk of developing breast cancer determined by family or personal history
postmenopausal women not on hormone replacement therapy for at minimum six months prior to corresponding aspiration
willing to participate in companion protocol (KUMC HSC#4601) for random periareolar fine needle aspiration (RPFNA) for correlational studies

Exclusion Criteria:

women who have been on raloxifene, tamoxifen, letrozole, anastrozole or exemestane within the six months prior to RPFNA.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00329017

Contacts

Contact: Bruce Kimler, Ph.D.

913-588-4523

bkimler@kumc.edu

Locations

United States, Kansas
University of Kansas Medical Center	Recruiting
Kansas City, Kansas, United States, 66160

Sponsors and Collaborators

University of Kansas

Intergenetics, Inc.

Investigators

Principal Investigator:

Carol J Fabian, MD

University of Kansas

More Information

No publications provided

Responsible Party:	University of Kansas Medical Center ( Carol Fabian MD )
Study ID Numbers:	9814
Study First Received:	May 19, 2006
Last Updated:	August 20, 2009
ClinicalTrials.gov Identifier:	NCT00329017 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Kansas:

SNPs
single nucleotide polymorphism
breast atypia
breast epithelial hyperplasia
high risk for breast cancer

Study placed in the following topic categories:

Hyperplasia
Skin Diseases
Breast Neoplasms
Breast Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Skin Diseases
Breast Neoplasms
Breast Diseases

ClinicalTrials.gov processed this record on September 11, 2009