CClinicalTrials.gg
Status unknownNCT01034891WARUpdated Dec 18, 2009

Women At Risk: The High Risk Breast Cancer Program

An observational study in Breast Cancer, sponsored by New York Presbyterian Hospital. Status unknown at 2 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2009-12-18.

Sponsored by New York Presbyterian Hospital · Observational

The sponsor has not verified this record recently (last verified Oct 2009), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
2,000
Ages
18 Years and older
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Breast Cancer

Browse trials for

Keywords

  • 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
03

In context

Breast Neoplasms

12,543 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's planned enrollment of 2,000 is above the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

New York Presbyterian Hospital is the lead sponsor of 20 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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

Exclusion Criteria:

  • DCIS (ductal carcinoma in situ)
  • previous diagnosis of breast cancer
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
2,000 participants (estimated)
06

Study locations

2 of 2 sites recruiting
  • 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
07

References and documents

Publications

  • 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. PubMed 18979140 ↗
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 18, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01034891
Lead sponsor
New York Presbyterian Hospital
Collaborators
Women At Risk
First posted
Dec 18, 2009
Start date
Jan 1991
Last update
Dec 18, 2009

Study contacts

Amy C Whiffen, MPH
Contact
awhiffen@womenatrisknyc.org
212-305-3238
Lisa Held, BA
Contact
lheld@womenatrisknyc.org
212-305-3269
Kathie-Ann Joseph, MD, MPH
principal investigator · Columbia University/New York Presbyterian Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2009. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion