Text Size

Women At Risk: The High Risk Breast Cancer Program (WAR)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2009 by New York Presbyterian Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Women At Risk
Information provided by:
New York Presbyterian Hospital
ClinicalTrials.gov Identifier:
NCT01034891
First received: December 17, 2009
Last updated: NA
Last verified: October 2009
History: No changes posted
  Purpose

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.


Condition
Breast Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Women At Risk: The High Risk Breast Cancer Program

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by New York Presbyterian Hospital:

Estimated Enrollment: 2000
Study Start Date: January 1991
Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

patients of the breast center at New York Presbyterian Hosptial/ Columbia University Medical Center

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01034891

Contacts
Contact: Amy C Whiffen, MPH 212-305-3238 awhiffen@womenatrisknyc.org
Contact: Lisa Held, BA 212-305-3269 lheld@womenatrisknyc.org

Locations
United States, New York
Women At Risk, Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Amy C Whiffen, MPH     212-305-3238     awhiffen@womenatrisknyc.org    
Women At Risk, Weill Cornell Recruiting
New York, New York, United States, 10065
Contact: Rhonda Theodore     212-821-0635     rtm9001@nyp.org    
Sponsors and Collaborators
New York Presbyterian Hospital
Women At Risk
Investigators
Principal Investigator: Kathie-Ann Joseph, MD, MPH Columbia University/New York Presbyterian Hospital
  More Information

Additional Information:
Women At Risk Website  This link exits the ClinicalTrials.gov site
Women At Risk blog  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Amy Whiffen, Women At Risk
ClinicalTrials.gov Identifier: NCT01034891     History of Changes
Other Study ID Numbers: AAAA4649
Study First Received: December 17, 2009
Last Updated: December 17, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by New York Presbyterian Hospital:
BRCA mutation
benign breast disease
family history of breast cancer
strong family history of breast cancer
 atypical ductal hyperplasia
atypical lobular hyperplasia
high risk for breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on May 19, 2013