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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:
ClinicalTrials.gov Identifier:
NCT00323908
First Posted: May 10, 2006
Last Update Posted: February 7, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
University of Alabama at Birmingham
Avon Foundation
National Cancer Institute (NCI)
Johns Hopkins University
Information provided by (Responsible Party):
Carol Fabian, MD, University of Kansas Medical Center Research Institute
  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 Carol Fabian, MD, University of Kansas Medical Center Research Institute:

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00323908


Sponsors and Collaborators
Carol Fabian, MD
University of Alabama at Birmingham
Avon Foundation
National Cancer Institute (NCI)
Johns Hopkins University
Investigators
Principal Investigator: Carol J Fabian, MD University of Kansas Medical Center
  More Information

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
First Submitted: May 8, 2006
First Posted: May 10, 2006
Last Update Posted: February 7, 2012
Last Verified: February 2012

Keywords provided by Carol Fabian, MD, University of Kansas Medical Center Research Institute:
Breast Cancer
prevention
tissue sampling
polymorphisms
steroid and carcinogen metabolism

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


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