MedDataX Logo

Women At Risk: The High Risk Breast Cancer Program

NCT ID: NCT01034891

Last Updated: 2009-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

1991-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Breast Cancer

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Women At Risk

AMBIG

Sponsor Role collaborator

New York Presbyterian Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Women At Risk

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Kathie-Ann Joseph, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Columbia University/New York Presbyterian Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Women At Risk, Columbia University Medical Center

New York, New York, United States

Site Status RECRUITING

Women At Risk, Weill Cornell

New York, New York, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Amy C Whiffen, MPH

Role: CONTACT

Phone: 212-305-3238

Email: [email protected]

Lisa Held, BA

Role: CONTACT

Phone: 212-305-3269

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Amy C Whiffen, MPH

Role: primary

Rhonda Theodore

Role: primary

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 18979140 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

http://nyp.org/services/war/index.html

Women At Risk Website

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

AAAA4649

Identifier Type: -

Identifier Source: org_study_id