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Protocol for Postmenopausal Women at Increased Risk of Developing Breast Cancer

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.
ClinicalTrials.gov Identifier: NCT00329017
Recruitment Status : Active, not recruiting
First Posted : May 24, 2006
Last Update Posted : February 14, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment
Breast Cancer Procedure: 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.

Study Design

Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Correlation of SNP Patterns With Fine Needle Aspiration Cytomorphology in High Risk Postmenopausal Women
Study Start Date : May 2005
Estimated Primary Completion Date : November 2017
Estimated Study Completion Date : November 2017

Resource links provided by the National Library of Medicine

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

Groups and Cohorts

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


Outcome Measures

Primary Outcome Measures :
  1. 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.


Biospecimen Retention:   Samples With DNA
Fine needle aspirate

Eligibility Criteria

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
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

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): 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 Medical Center
More Information

Responsible Party: Carol Fabian, MD, Professor, Director Breast Cancer Prevention Unit, University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT00329017     History of Changes
Other Study ID Numbers: 9814
First Posted: May 24, 2006    Key Record Dates
Last Update Posted: February 14, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Global results will be published.

Keywords provided by Carol Fabian, MD, University of Kansas Medical Center:
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