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

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ClinicalTrials.gov Identifier: NCT00323908
Recruitment Status : Completed
First Posted : May 10, 2006
Last Update Posted : February 7, 2012
Sponsor:
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

Brief Summary:
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 or disease
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.

Study Type : Observational
Actual Enrollment : 281 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: QM-MSP, Ki-67, and Cytomorphology of RPFNA Specimens From High Risk Women
Study Start Date : June 2005
Primary Completion Date : November 2008
Study Completion Date : November 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Group/Cohort
1
Women at high risk for developing breast cancer




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

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

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 Posted: May 10, 2006    Key Record Dates
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