NCT00849199

Brief Summary

The purpose of this study is to collect information from a large group of women who may have a greater chance to develop cancer because of their own personal history of cancer or because of their family history of cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,452

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2001

Longer than P75 for all trials

Geographic Reach
1 country

3 active sites

Status
completed

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

July 1, 2001

Completed
7.6 years until next milestone

First Submitted

Initial submission to the registry

February 20, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 23, 2009

Completed
8.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

May 6, 2020

Status Verified

May 1, 2020

Enrollment Period

16.5 years

First QC Date

February 20, 2009

Last Update Submit

May 4, 2020

Conditions

Keywords

screeningearly detectionpreventioncancerhigh riskovarian cancerbreast cancer

Outcome Measures

Primary Outcomes (1)

  • To create a registry for women at high risk of breast or ovarian cancer

    15 years

Secondary Outcomes (1)

  • To provide genetic counseling, referrals for diagnostic tests and to appropriate clinics to promote the early detection of cancer; to seek and develop research protocols of early detection and treatment

    15 years

Study Arms (1)

High risk of breast or ovarian cancer

Eligibility Criteria

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

Primarily disadvantaged women who have a family history of breast and or ovarian cancer or who have had a personal history of breast and or ovarian cancer or who themselves or a relative have positive genetic markers for breast or ovarian cancer.

You may qualify if:

  • Female or male over the age of 18.
  • Patients who have a family history of breast and or ovarian cancer.
  • Patients who have had a personal history of breast and or ovarian cancer or who themselves or a relative have positive genetic markers for breast or ovarian cancer.
  • Patients who seek medical screening and risk assessment for perceived increased risk of breast or ovarian cancer.

You may not qualify if:

  • Women with psychiatric, psychological or other conditions which prevent fully informed consent.
  • Patients seeking medical attention not related to the purposes of this protocol, (e.g. those seeking treatment of a known cancer).
  • Women with a history of any medical condition, which places the subject at risk, related to the need for donating blood for research purposes, (e.g., chronic infectious diseases, severe anemia, or hemophilia).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Bellevue Hospital

New York, New York, 10016, United States

Location

NYU Cancer Center

New York, New York, 10016, United States

Location

NYU Tisch Hospital

New York, New York, 10016, United States

Location

Related Publications (1)

  • Smith J, Baer L, Blank S, Dilawari A, Carapetyan K, Alvear M, Utate M, Curtin J, Muggia F. A screening and prevention programme serving an ethnically diverse population of women at high risk of developing breast and/or ovarian cancer. Ecancermedicalscience. 2009;3:123. doi: 10.3332/ecancer.2008.123. Epub 2009 Mar 16.

MeSH Terms

Conditions

Ovarian NeoplasmsBreast NeoplasmsNeoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Franco Muggia, MD

    NYU Langone Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2009

First Posted

February 23, 2009

Study Start

July 1, 2001

Primary Completion

January 1, 2018

Study Completion

January 1, 2018

Last Updated

May 6, 2020

Record last verified: 2020-05

Locations