Protocol for Postmenopausal Women at Increased Risk of Developing Breast Cancer

October 7, 2019 updated by: Carol Fabian, MD

Correlation of SNP Patterns With Fine Needle Aspiration Cytomorphology in High Risk Postmenopausal Women

A study to examine the potential associations between common single nucleotide polymorphisms and pre-cancerous conditions in breast tissue specimens from postmenopausal women.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

A study to examine the correlation between single nucleotide polymorphisms (SNPs) affecting steroid and carcinogen metabolism and benign breast tissue cytomorphology collected via random periareolar fine needle aspiration in postmenopausal women at increased risk for breast cancer and taking hormone replacement therapy.

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center

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

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Post menopausal women, on or off hormone replacement therapy, at high risk of developing breast cancer

Description

Inclusion Criteria:

  • postmenopausal women on or off hormone replacement therapy
  • at high risk of developing breast cancer determined by family or personal history
  • postmenopausal women not on hormone replacement therapy for at minimum six months prior to corresponding aspiration
  • willing to participate in companion protocol (KUMC HSC#4601) for random periareolar fine needle aspiration (RPFNA) for correlational studies

Exclusion Criteria:

  • 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
Intervention / Treatment
1
Post-menopausal women who are at increased risk for development of breast cancer on the basis of family or personal history.
Procedure: Fine needle aspiration
Fine needle aspiration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation of SNP patterns with cytlomorphology of breast fine needle aspirates.
Time Frame: ongoing
develoment of algorithm for prediction of risk of developing breast cancer.
ongoing

Collaborators and Investigators

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

Sponsor

Carol Fabian, MD

Collaborators

Intergenetics, Inc.

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

May 1, 2005

Primary Completion (Actual)

November 12, 2015

Study Completion (Actual)

November 12, 2015

Study Registration Dates

First Submitted

May 19, 2006

First Submitted That Met QC Criteria

May 19, 2006

First Posted (Estimate)

May 24, 2006

Study Record Updates

Last Update Posted (Actual)

October 10, 2019

Last Update Submitted That Met QC Criteria

October 7, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9814

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Global results will be published.

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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