NYU Ovarian Cancer Early Detection Program Blood and Genetics

January 10, 2011 updated by: NYU Langone Health

Improving current strategies for detection of early stage disease can impact favorably on long-term survival of women with ovarian cancer. To reduce the morbidity and mortality of ovarian cancer, screening for this disease must detect early stage disease rather than advanced stage disease. Thus the challenge for the future is to identify and develop highly sensitive and specific tumor markers that can be applied to population-based screening for the early detection of ovarian cancer.

Study Overview

Status

Terminated

Conditions

Ovarian Cancer

Detailed Description

The aim of NYU Ovarian Cancer Early Detection Program is to establish an effective, early detection program employing state-of-the-art science and technology in collaboration with other nationally recognized clinicians and scientists.

This proposed research study will foster collaboration between clinicians and scientists that will facilitate the rapid identification of a set of molecular, biochemical, functional, and genetic markers which can be employed to effectively detect and manage ovarian cancer and other gynecological malignancies.

Study Type

Observational

Enrollment (Actual)

890

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- New York
  - New York, New York, United States, 10016
    - NYUCancer Institute Clinical Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

women noted to be at increased risk for developing ovarian cancer

Description

Inclusion Criteria:

Women enrolled in the NYU Ovarian Cancer Early Detection Program have at least one of the following risk factors:

A personal history of breast cancer
One or more first degree relatives (mother, sister, daughter) with ovarian cancer
Multiple family members with either breast and/or ovarian cancer
A personal history of a positive BRCA1 or BRCA2 genetic test result
A close relative with a positive BRCA1 or BRCA2 genetic test result
A personal history of colon or endometrial cancer with at least two relatives with a Lynch/HNPCC-associated cancer (colorectal, endometrial, small bowel, ureter, or renal pelvis cancer)
Synchronous or metachronous endometrial and colorectal cancer
A personal history of a mismatch repair gene mutation (MLH1, MSH2, MSH6 or PMS2)
A close relative with a mismatch repair gene mutation (MLH1, MSH2, MSH6 or PMS2)
A personal history of colorectal or endometrial cancer with a mismatch repair defect (ie. Microsatellite instability (MSI) or immunohistochemical loss of expression of MLH1, MSH2, MSH6, or PMS2)
The use of fertility drugs for more than one year

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
NYU OCEDP Population

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
identification and development of highly sensitive and specific tumor markers for ovarian cancer Time Frame: 5 years	5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NYU Langone Health

Investigators

Principal Investigator: Bhavana Pothuri, M.D., NYU Langone Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2004

Study Completion (ACTUAL)

November 1, 2010

Study Registration Dates

First Submitted

September 18, 2007

First Submitted That Met QC Criteria