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

This study has been completed.
Sponsor:
Collaborators:
University of Alabama at Birmingham
Avon Foundation
Johns Hopkins University
Information provided by (Responsible Party):
Carol Fabian, MD, University of Kansas Medical Center Research Institute
ClinicalTrials.gov Identifier:
NCT00323908
First received: May 8, 2006
Last updated: February 6, 2012
Last verified: February 2012
  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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: QM-MSP, Ki-67, and Cytomorphology of RPFNA Specimens From High Risk Women

Resource links provided by NLM:


Further study details as provided by University of Kansas:

Enrollment: 281
Study Start Date: June 2005
Study Completion Date: November 2008
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00323908

Sponsors and Collaborators
Carol Fabian, MD
University of Alabama at Birmingham
Avon Foundation
Johns Hopkins University
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: NCT00323908     History of Changes
Other Study ID Numbers: 9933
Study First Received: May 8, 2006
Last Updated: February 6, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Kansas:
Breast Cancer
prevention
tissue sampling
polymorphisms
steroid and carcinogen metabolism

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

ClinicalTrials.gov processed this record on November 25, 2014