Women At Risk: The High Risk Breast Cancer Program

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Study Start

1991-01

Primary Completion

N/A

Study Completion

N/A

Enrollment (ESTIMATED)

2000

Study Overview

Women At Risk: The High Risk Breast Cancer Program

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.

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.

Breast Cancer

AAAA4649

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2009-12-17	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2009-12-17
First Submitted that Met QC Criteria 2009-12-17	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2009-12-18
First Posted (ESTIMATED) 2009-12-18	Results First Posted N/A	Last Verified 2009-10

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
N/A

Allocation:
N/A

Interventional Model:
N/A

Masking:
N/A

Arms and Interventions

Participant Group/Arm	Intervention/Treatment

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Amy C Whiffen, MPH

Phone Number: 212-305-3238

Email: awhiffen@womenatrisknyc.org

Study Contact Backup

Name: Lisa Held, BA

Phone Number: 212-305-3269

Email: lheld@womenatrisknyc.org

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
FEMALE

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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)

DCIS (ductal carcinoma in situ)
previous diagnosis of breast cancer

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Women At Risk

Investigators

PRINCIPAL_INVESTIGATOR: Kathie-Ann Joseph, MD, MPH, Columbia University/New York Presbyterian Hospital

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.

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