Women At Risk: The High Risk Breast Cancer Program | NCT01034891

Studies
Women At Risk: The High Risk Breast Cancer Program

NCT01034891

Sponsor

New York Presbyterian Hospital

Status

Unknown status

Last Update Posted

Dec 18, 2009Estimated

Enrollment

2,000Estimated

Phase

Not provided

Conditions

Breast Cancer

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1991

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Dec 17, 2009

First Submission Date that Met QC Criteria

Dec 17, 2009

First Posted Date

Dec 18, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 17, 2009

Last Update Posted Date

Dec 18, 2009Estimated

Name	Class
Women At Risk	AMBIG

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2,000Estimated

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Amy C Whiffen, MPH	Contact	212-305-3238		awhiffen@womenatrisknyc.org
Lisa Held, BA	Contact	212-305-3269		lheld@womenatrisknyc.org

Overall Officials

Name	Affiliation	Role
Kathie-Ann Joseph, MD, MPH	Columbia University/New York Presbyterian Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Women At Risk, Columbia University Medical Center	Recruiting	New York	New York	10032	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
18979140	Result	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.

ID	Term
D001943	Breast Neoplasms
D003550	Cystic Fibrosis
D002285	Carcinoma, Intraductal, Noninfiltrating

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases