Protocol for Postmenopausal Women at Increased Risk of Developing Breast Cancer

This study is currently recruiting participants.

Verified by University of Kansas, September 2008

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

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

U.S. FDA Resources

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

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 2009
Estimated Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
1 Oncovue test	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: Valerie Hahn

913-588-3375

vhahn@kumc.edu

Locations

United States, Kansas
University of Kansas Medical Center	Recruiting
Kansas City, Kansas, United States, 66160
Contact: Valerie Hahn 913-588-3375 vhahn@kumc.edu

Sponsors and Collaborators

University of Kansas

Intergenetics, Inc.

Investigators

Principal Investigator:

Carol J Fabian, MD

University of Kansas

More Information

Responsible Party:	University of Kansas Medical Center ( Carol Fabian MD )
Study ID Numbers:	9814
Study First Received:	May 19, 2006
Last Updated:	September 15, 2008
ClinicalTrials.gov Identifier:	NCT00329017
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

ClinicalTrials.gov processed this record on January 15, 2009