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

NCT ID: NCT00323908

Last Updated: 2023-05-22

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

COMPLETED

Total Enrollment

281 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-06-30

Study Completion Date

2008-11-30

Brief Summary

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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.

Detailed Description

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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.

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

Women at high risk for developing breast cancer

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Alabama at Birmingham

OTHER

Sponsor Role collaborator

Avon Foundation

OTHER

Sponsor Role collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Johns Hopkins University

OTHER

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

Other Identifiers

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9933

Identifier Type: -

Identifier Source: org_study_id

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