Protocol for Women at Increased Risk of Developing Breast Cancer - Full Text View

Sponsor:	University of Kansas
Information provided by:	University of Kansas
ClinicalTrials.gov Identifier:	NCT00291096

Purpose

The overall goal of this project is to develop an integrative system of breast cancer risk assessment based on epidemiologic and biologic risk variables, as well as to develop or refine risk biomarkers which may be useful in predicting and monitoring response to prevention interventions.

Condition
Breast Cancer

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	High Risk Breast Clinic: Protocol for Women at Increased Risk for Developing Breast Cancer

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 Without DNA

Biospecimen Description:

RPFNA specimens, serum, NAF

Estimated Enrollment:	3000
Study Start Date:	January 1989

Groups/Cohorts
1 Post-menopausal women who are at increased risk for development of breast cancer on the basis of family or personal history.

Detailed Description:

To correlate established risk biomarkers such as cytomorphology obtained from random periareolar fine needle aspiration ( RPFNA), mammographic breast density, serum bioavailable estradiol and IGF-1/IGFBP-3 with each other and with 5-10 year Gail risk estimates. Where available, and with appropriate safe guards to maintain status for breast cancer susceptibility genes may be included.
To determine the relative predictive value of established risk biomarkers for the development of DCIS and/or invasive cancer.
To evaluate potential new breast tissue-based biomarkers including Ki-67, PCNA, ER, COX-2, aromatase, methylation of key tumor suppressor genes (i.e., RAR, p16, etc), proteomic patterns in RPFNA and nipple aspirate fluid (NAF), as well as NAF hormone levels, and correlate them with other risk biomarkers listed in 1.
To determine the prevalence of polymorphisms of a panel of genes important in hormone and xenobiotic metabolism as well as DNA repair and correlate these polymorphisms with established risk biomarkers listed in 1, as well as with development of DCIS and invasive cancer.
To maintain contact with this initially identified cohort of high risk women, acquire demographic data, biologic specimens and data and follow them prospectively for the development.

Eligibility

Ages Eligible for Study:	30 Years to 65 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

Self-identified women at high risk for development of breast cancer

Criteria

Inclusion Criteria:

women with at least 2 times the normal risk of developing breast cancer
between the ages of 30-65 (or within 10 years of youngest age at diagnosis in first degree relative)
greater than six months from ingestion of antihormonal therapy
greater than 1 year from pregnancy, lactation, or chemotherapy
willing to have a mammogram within six months prior to RPFNA
willing to discontinue NSAIDS or herbal supplements
willing to have blood drawn

Exclusion Criteria:

no metastatic malignancy of any kind
no breast implants or tram flap reconstructions
no radiation to both breasts
no women who have a current mammogram or clinical breast exam suspicious for cancer

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00291096

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
Principal Investigator: Carol J Fabian, MD
Principal Investigator: Bruce Kimler, PhD

Sponsors and Collaborators

University of Kansas

Investigators

Principal Investigator:

Carol J Fabian, MD

University of Kansas

More Information

No publications provided

Responsible Party:	University of Kansas Medical Center ( Carol J. Fabian )
Study ID Numbers:	4601
Study First Received:	February 10, 2006
Last Updated:	August 20, 2009
ClinicalTrials.gov Identifier:	NCT00291096 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Kansas:

breast atypia
fine needle aspiration
high risk for breast cancer
breast epithelial hyperplasia

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Skin Diseases
Breast Neoplasms
Breast Diseases

ClinicalTrials.gov processed this record on February 08, 2010