We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2009 by New York Presbyterian Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01034891
First Posted: December 18, 2009
Last Update Posted: December 18, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Women At Risk
Information provided by:
New York Presbyterian Hospital
  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:


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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
  Contacts and Locations
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
  More Information

Additional Information:
Publications:
Responsible Party: Amy Whiffen, Women At Risk
ClinicalTrials.gov Identifier: NCT01034891     History of Changes
Other Study ID Numbers: AAAA4649
First Submitted: December 17, 2009
First Posted: December 18, 2009
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