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Trial record 1 of 1 for:    NCT00531778
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NYU Ovarian Cancer Early Detection Program Blood and Genetics

This study has been terminated.
(insufficient funding and resource)
Sponsor:
Information provided by:
New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT00531778
First received: September 18, 2007
Last updated: January 10, 2011
Last verified: January 2011
History of Changes
  Purpose

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.


Condition
Ovarian Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: NYU Ovarian Cancer Early Detection Program Blood and Genetics

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by New York University School of Medicine:

Primary Outcome Measures:
  • identification and development of highly sensitive and specific tumor markers for ovarian cancer [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

whole blood, serum, plasma, urine, ovarian tissue


Enrollment: 890
Study Start Date: June 2004
Study Completion Date: November 2010
Groups/Cohorts
NYU OCEDP Population

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

women noted to be at increased risk for developing ovarian cancer

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00531778

Locations
United States, New York
NYUCancer Institute Clinical Cancer Center
New York, New York, United States, 10016
Sponsors and Collaborators
New York University School of Medicine
Investigators
Principal Investigator: Bhavana Pothuri, M.D. New York University School of Medicine
  More Information

No publications provided

Responsible Party: Bhavana Pothuri, M.D., NYU Cancer Institute
ClinicalTrials.gov Identifier: NCT00531778     History of Changes
Other Study ID Numbers: NYU 04-30 H11938
Study First Received: September 18, 2007
Last Updated: January 10, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by New York University School of Medicine:
Women with increased risk for developing ovarian cancer
early detection
biomarker for ovarian cancer

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
 Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders

ClinicalTrials.gov processed this record on May 23, 2013