Comprehensive Screening for Women at High Genetic Risk for Developing Breast Cancer

NCT ID: NCT00255060

Last Updated: 2010-07-20

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

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2001-11-30

Study Completion Date

2007-06-30

Brief Summary

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To screen women who are high risk for breast cancer with breast MRI, mammogram and random periareolar fine needle aspiration.

Detailed Description

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General Purpose: The purpose of our protocol is develop a comprehensive screening protocol for women at high risk for developing breast cancer in the hopes of detecting breast cancer or it's precursor lesions at the earliest possible stage and reducing breast cancer mortality.

The following are our specific goals in this endeavor;

1. To assess the sensitivity and specificity of MRI in breast cancer detection in women at high risk compared to mammography
2. To assess the ability of random periareolar fine needle aspiration to detect abnormal ductal cells and to correlate these results with MRI and mammogram findings
3. To assess appropriate screening intervals for BRCA1/2 mutation carriers and women with a \>10% risk of developing breast cancer in ten years The following aims will be outlined in detail under methodology.

Conditions

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Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

May have had previous breast or ovarian cancer, but must be at least one year out from treatment of a Stage 1 or early 2 cancer.
Minimum Eligible Age

25 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

United States Department of Defense

FED

Sponsor Role collaborator

Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Stanford University School of Medicine

Principal Investigators

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James M Ford

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Stanford University School of Medicine

Stanford, California, United States

Site Status

Countries

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United States

Other Identifiers

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77716

Identifier Type: -

Identifier Source: secondary_id

BRSNSTU0002

Identifier Type: -

Identifier Source: secondary_id

NCT00255060

Identifier Type: -

Identifier Source: secondary_id

BRSNSTU0002

Identifier Type: -

Identifier Source: org_study_id

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