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

May 18, 2023 updated by: Carol Fabian, MD

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

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.

Study Overview

Status

Completed

Conditions

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

Enrollment (Actual)

281

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

medical center

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Carol Fabian, MD

Collaborators

Johns Hopkins University
National Cancer Institute (NCI)
University of Alabama at Birmingham
Avon Foundation

Investigators

  • Principal Investigator: Carol J Fabian, MD, University of Kansas Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2005

Primary Completion (Actual)

November 1, 2008

Study Completion (Actual)

November 1, 2008

Study Registration Dates

First Submitted

May 8, 2006

First Submitted That Met QC Criteria

May 8, 2006

First Posted (Estimate)

May 10, 2006

Study Record Updates

Last Update Posted (Actual)

May 22, 2023

Last Update Submitted That Met QC Criteria

May 18, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9933 (Other Identifier: CTRP (Clinical Trial Reporting Program))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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