National Ovarian Cancer Early Detection Program Blood and Genetics - Full Text View

Sponsor:	New York University School of Medicine
Collaborator:	National Cancer Institute (NCI)
Information provided by:	New York University School of Medicine
ClinicalTrials.gov Identifier:	NCT00531778

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:	Prospective
Official Title:	National Ovarian Cancer Early Detection Program Blood and Genetics

Resource links provided by NLM:

MedlinePlus related topics: Cancer Ovarian Cancer

U.S. FDA Resources

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

Estimated Enrollment:	5000
Study Start Date:	June 2004

Groups/Cohorts
• NOCEDP Population Women noted to be at increased risk for developing ovarian cancer and are enrolled in the National Ovarian Cancer Early Detection Program; Women enrolled in the National Ovarian Cancer Early Detection Program have at least one of the following risk factors: A personal history of breast, colon or urinary 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 The use of fertility drugs for more than one year History of ovarian cancer/tumors with any residual ovarian tissue remaining post surgical intervention
• Gyne or Gyne/Onc Population Women with a diagnosis of a reproductive cancer or a benign gynecological condition (such as uterine leiomyomata, endometriosis, pelvic inflammatory disease, follicular or corpus luteum ovarian cysts), women with a highly suspicious adnexal mass or women noted to be at increased risk for developing ovarian cancer.
• Control Population Apparently healthy women who are neither at high risk of developing ovarian cancer nor have a gynecological condition.

Detailed Description:

The aim of the National 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:	Yes

Criteria

Inclusion Criteria:

• NOCEDP Population - women noted to be at increased risk for developing ovarian cancer and are enrolled in the National Ovarian Cancer Early Detection Program;

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

A personal history of breast, colon or urinary 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
The use of fertility drugs for more than one year
History of ovarian cancer/tumors with any residual ovarian tissue remaining post surgical intervention
- Gyne or Gyne/Onc Population - women with a diagnosis of a reproductive cancer or a benign gynecological condition (such as uterine leiomyomata, endometriosis, pelvic inflammatory disease, follicular or corpus luteum ovarian cysts), women with a highly suspicious adnexal mass or women noted to be at increased risk for developing ovarian cancer
- Control Population - apparently healthy women who are neither at high risk of developing ovarian cancer nor have a gynecological condition.

Contacts and Locations

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

Contacts

Contact: David Fishman, M.D.	212-263-7141	david.fishman@med.nyu.edu
Contact: Mary Ann Doran, R.N., BSN	212-731-5617

Locations

United States, New York
NYUCancer Institute Clinical Cancer Center	Recruiting
New York, New York, United States, 10016
Contact: David Fishman, M.D. david.fishman@med.nyu.edu
Contact: Maryann Doran, R.N 212-731-5617
Principal Investigator: Davis Fishman, M.D.

Sponsors and Collaborators

New York University School of Medicine

National Cancer Institute (NCI)

Investigators

Principal Investigator:

David Fishman, M.D.

New York University School of Medicine

More Information

No publications provided

Responsible Party:	New York University School of Medicine ( David Fishman, M.D. )
Study ID Numbers:	NYU 04-30 H11938, NYU 04-30, H11938
Study First Received:	September 18, 2007
Last Updated:	May 22, 2008
ClinicalTrials.gov Identifier:	NCT00531778 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by New York University School of Medicine:

Women with increased risk for developing ovarian cancer
Women diagnosed with reproductive cancer
Women with benign gynecological condition
Apparently healthy women

Additional relevant MeSH terms:

Genital Diseases, Female
Neoplasms
Neoplasms by Site
Ovarian Neoplasms
Gonadal Disorders
Genital Neoplasms, Female

Endocrine System Diseases
Urogenital Neoplasms
Ovarian Diseases
Adnexal Diseases
Endocrine Gland Neoplasms

ClinicalTrials.gov processed this record on November 20, 2009