Protocol for Postmenopausal Women at Increased Risk of Developing Breast Cancer

NCT ID: NCT00329017

Last Updated: 2019-10-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2005-05-31

Study Completion Date

2015-11-12

Brief Summary

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

Detailed Description

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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.

Conditions

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Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1

Post-menopausal women who are at increased risk for development of breast cancer on the basis of family or personal history.

Fine needle aspiration

Intervention Type PROCEDURE

Fine needle aspiration

Interventions

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Fine needle aspiration

Fine needle aspiration

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Intergenetics, Inc.

INDUSTRY

Sponsor Role collaborator

Carol Fabian, MD

OTHER

Sponsor Role lead

Responsible Party

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Carol Fabian, MD

Professor, Director Breast Cancer Prevention Unit

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Carol J Fabian, MD

Role: PRINCIPAL_INVESTIGATOR

University of Kansas Medical Center

Locations

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University of Kansas Medical Center

Kansas City, Kansas, United States

Site Status

Countries

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United States

Other Identifiers

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9814

Identifier Type: -

Identifier Source: org_study_id

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