NYU Ovarian Cancer Early Detection Program Blood and Genetics

NCT ID: NCT00531778

Last Updated: 2011-01-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

890 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-06-30

Study Completion Date

2010-11-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Ovarian Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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NYU OCEDP Population

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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NYU Cancer Institute

Principal Investigators

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Bhavana Pothuri, M.D.

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

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NYUCancer Institute Clinical Cancer Center

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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NYU 04-30 H11938

Identifier Type: -

Identifier Source: org_study_id

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