Protocol to Examine Methylation of Tumor Suppression Genes in Women at High Risk of Developing Breast Cancer

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators:	University of Kansas University of Alabama at Birmingham Avon Foundation National Cancer Institute (NCI) Johns Hopkins University
Information provided by:	University of Kansas
ClinicalTrials.gov Identifier:	NCT00323908

Purpose

A study to examine the correlations between methylation of various genes associated with breast cancer and proliferation and cytomorphology in breast epithelial cells acquired by random periareolar fine needle aspiration of women at high risk for development of breast cancer.

Condition
Breast Cancer

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:	QM-MSP, Ki-67, and Cytomorphology of RPFNA Specimens From High Risk Women

Further study details as provided by University of Kansas:

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	500
Study Start Date:	June 2005
Estimated Study Completion Date:	November 2008
Estimated Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Groups/Cohorts
1 Women at high risk for developing breast cancer

Detailed Description:

A study to examine the correlation between gene promotor methylation and benign breast tissue proliferation and cytomorphology collected via random periareolar fine needle aspiration in postmenopausal women at increased risk for breast cancer.

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

medical center

Criteria

Inclusion criteria:

women at high risk of developing breast cancer determined by family or personal history
willing to participate in companion protocol (KUMC HSC#4601) for random periareolar fine needle aspiration (RPFNA) for correlational studies

Exclusion criteria:

exclude 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: NCT00323908

Locations

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

Sponsors and Collaborators

University of Kansas

University of Alabama at Birmingham

Avon Foundation

National Cancer Institute (NCI)

Johns Hopkins University

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:	9933
Study First Received:	May 8, 2006
Last Updated:	September 15, 2008
ClinicalTrials.gov Identifier:	NCT00323908
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Kansas:

Breast Cancer
prevention
tissue sampling
polymorphisms
steroid and carcinogen metabolism

Study placed in the following topic categories:

Skin Diseases
Breast Neoplasms
Breast Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 14, 2009