NCT01034891

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,000

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1991

Completed
19 years until next milestone

First Submitted

Initial submission to the registry

December 17, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 18, 2009

Completed
Last Updated

December 18, 2009

Status Verified

October 1, 2009

First QC Date

December 17, 2009

Last Update Submit

December 17, 2009

Conditions

Breast Cancer

Keywords

BRCA mutationbenign breast diseasefamily history of breast cancerstrong family history of breast canceratypical ductal hyperplasiaatypical lobular hyperplasiahigh risk for breast cancer

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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)

You may not qualify if:

  • DCIS (ductal carcinoma in situ)
  • previous diagnosis of breast cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Women At Risk, Columbia University Medical Center

New York, New York, 10032, United States

RECRUITING

Women At Risk, Weill Cornell

New York, New York, 10065, United States

RECRUITING

Related Publications (1)

  • 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.

    PMID: 18979140RESULT

Related Links

MeSH Terms

Conditions

Breast NeoplasmsCystic FibrosisCarcinoma, Intraductal, Noninfiltrating

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesPancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeBreast Carcinoma In SituCarcinoma in SituNeoplasms, Ductal, Lobular, and Medullary

Study Officials

  • Kathie-Ann Joseph, MD, MPH

    Columbia University/New York Presbyterian Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Amy C Whiffen, MPH

CONTACT

212-305-3238awhiffen@womenatrisknyc.org

Lisa Held, BA

CONTACT

212-305-3269lheld@womenatrisknyc.org

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 17, 2009

First Posted

December 18, 2009

Study Start

January 1, 1991

Last Updated

December 18, 2009

Record last verified: 2009-10

Locations

US(2)