Breast CancerWARNCT01034891
Women At Risk: The High Risk Breast Cancer Program
An observational study of Breast Cancer, run by New York Presbyterian Hospital at 2 sites in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- How many people
- 2,000 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 1991to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: patients of the breast center at New York Presbyterian Hosptial/ Columbia University Medical Center
Who may be able to join
- 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)
Who cannot join
- DCIS (ductal carcinoma in situ)
- previous diagnosis of breast cancer
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
Women At Risk, Columbia University Medical Center
New York, New York, 10032
Amy C Whiffen, MPH, 212-305-3238, awhiffen@womenatrisknyc.org
- Recruiting
Women At Risk, Weill Cornell
New York, New York, 10065
Rhonda Theodore, 212-821-0635, rtm9001@nyp.org
About this study
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.
- Conditions
- Breast Cancer
- 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
- Medical subject headings
- Breast Neoplasms, Cystic Fibrosis, Carcinoma, Intraductal, Noninfiltrating
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2009 (estimated)
- Study startJan 1991
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- New York Presbyterian Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Women At Risk
- Investigators
- Kathie-Ann Joseph, MD, MPH, Principal investigator, Columbia University/New York Presbyterian Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01034891
- Sponsor's protocol ID
- AAAA4649
- Acronym
- WAR
- Status last verified
- Oct 2009
- First submitted
- 17 Dec 2009
- Last updated
- 18 Dec 2009
- Results posted
- No
- Data monitoring committee
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Women At Risk: The High Risk Breast Cancer Program
- ClinicalTrials.gov ID
- NCT01034891
- Acronym / sponsor ID
- WAR / AAAA4649
- Conditions
- Breast Cancer
- 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
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- New York Presbyterian HospitalUniversity, hospital or other
- Collaborators
- Women At Risk
- Study start
- Jan 1991
- First posted
- 18 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients of the breast center at New York Presbyterian Hosptial/ Columbia University Medical Center
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (2 listed)
- DCIS (ductal carcinoma in situ)
- previous diagnosis of breast cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2009.
- Results publication: PubMed 18979140Chun 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.
- Women At Risk WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathie-Ann Joseph, MD, MPH principal investigator
Columbia University/New York Presbyterian Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by New York Presbyterian Hospital at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amy C Whiffen, MPH (212-305-3238, awhiffen@womenatrisknyc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01034891, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2009; AzTrials last refreshed its copy on 6 Nov 2026.