Women At Risk: The High Risk Breast Cancer Program NCT01034891

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number	NCT01034891
Other study ID #	AAAA4649
Secondary ID
Status	Recruiting
Phase	N/A
First received	December 17, 2009
Last updated	December 17, 2009
Start date	January 1991

Study information
Verified date	October 2009
Source	New York Presbyterian Hospital
Contact	Amy C Whiffen, MPH
Phone	212-305-3238
Email	awhiffen[@]womenatrisknyc.org
Is FDA regulated	No
Health authority	United States: Institutional Review Board
Study type	Observational

Clinical Trial Summary

The purpose of this study is to increase understanding of women who are at high risk for developing breast cancer. Data from this group will be collected and entered into a registry. This registry serves as a clinical database to support research in prevention, early detection and treatment of breast cancer.

Description:

This is a longitudinal cohort study that collects data of eligible women at risk for developing breast cancer. Patient information will be entered into a secured computerized database that is used for research on the prevention, early detection and treatment of breast cancer.

Recruitment information / eligibility
Status	Recruiting
Enrollment	2000
Est. completion date
Est. primary completion date
Accepts healthy volunteers	No
Gender	Female
Age group	18 Years and older
Eligibility	Inclusion Criteria: - one or more first-degree relatives (mother, daughter, or sister) with pre-menopausal breast cancer - two or more first-degree relatives with post-menopausal breast cancer - tested positive for a BRCA1 or BRCA2 mutation - a history of biopsy-proven atypical ductal hyperplasia or atypical lobular hyperplasia - a history of biopsy-proven lobular neoplasia (lobular carcinoma in situ) Exclusion Criteria: - DCIS (ductal carcinoma in situ) - previous diagnosis of breast cancer

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

Locations
Country	Name	City	State
United States	Women At Risk, Columbia University Medical Center	New York	New York
United States	Women At Risk, Weill Cornell	New York	New York

Sponsors *(2)*
Lead Sponsor	Collaborator
New York Presbyterian Hospital	Women At Risk

Country where clinical trial is conducted

United States,

References & Publications (1)

Chun J, Pocock B, Joseph KA, El-Tamer M, Klein L, Schnabel F. Breast cancer risk factors in younger and older women. Ann Surg Oncol. 2009 Jan;16(1):96-9. doi: 10.1245/s10434-008-0176-8. Epub 2008 Nov 1. — View Citation

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External Links

Women At Risk Website

Women At Risk: The High Risk Breast Cancer Program

Clinical Trial Details — Status: Recruiting

Administrative data

Study information