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

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ClinicalTrials.gov Identifier: NCT01034891
Recruitment Status : Unknown
Verified October 2009 by New York Presbyterian Hospital.
Recruitment status was:  Recruiting
First Posted : December 18, 2009
Last Update Posted : December 18, 2009
Sponsor:
Collaborator:
Women At Risk
Information provided by:
New York Presbyterian Hospital

Brief 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.

Condition or disease
Breast Cancer

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.

Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Women At Risk: The High Risk Breast Cancer Program
Study Start Date : January 1991

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources





Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Publications of Results:
Responsible Party: Amy Whiffen, Women At Risk
ClinicalTrials.gov Identifier: NCT01034891     History of Changes
Other Study ID Numbers: AAAA4649
First Posted: December 18, 2009    Key Record Dates
Last Update Posted: December 18, 2009
Last Verified: October 2009

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