Protocol for Postmenopausal Women at Increased Risk of Developing Breast Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Intergenetics, Inc.
Information provided by (Responsible Party):
Carol Fabian, MD, University of Kansas Medical Center Research Institute
ClinicalTrials.gov Identifier:
NCT00329017
First received: May 19, 2006
Last updated: July 25, 2014
Last verified: July 2014
  Purpose

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


Condition Intervention
Breast Cancer
Procedure: Fine needle aspiration

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Correlation of SNP Patterns With Fine Needle Aspiration Cytomorphology in High Risk Postmenopausal Women

Resource links provided by NLM:


Further study details as provided by University of Kansas:

Primary Outcome Measures:
  • Correlation of SNP patterns with cytlomorphology of breast fine needle aspirates. [ Time Frame: ongoing ] [ Designated as safety issue: No ]
    develoment of algorithm for prediction of risk of developing breast cancer.


Biospecimen Retention:   Samples With DNA

Fine needle aspirate


Estimated Enrollment: 500
Study Start Date: May 2005
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
Other Name: Fine needle aspiration

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.

  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

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

Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00329017

Locations
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
Carol Fabian, MD
Intergenetics, Inc.
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: NCT00329017     History of Changes
Other Study ID Numbers: 9814
Study First Received: May 19, 2006
Last Updated: July 25, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Kansas:
SNPs
single nucleotide polymorphism
breast atypia
breast epithelial hyperplasia
high risk for breast cancer

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

ClinicalTrials.gov processed this record on August 28, 2014