NYU Ovarian Cancer Early Detection Program Blood and Genetics

Ovarian Cancer Clinical Trial

Official title:

NYU Ovarian Cancer Early Detection Program Blood and Genetics

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00531778
• Other study ID #: NYU 04-30 H11938
• Status: Terminated
• Phase: N/A
• First received: September 18, 2007
• Last updated: January 10, 2011
• Start date: June 2004
• Est. completion date: November 2010

Study information

• Verified date: January 2011
• Source: New York University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 890
• Est. completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Ovarian Cancer
• Ovarian Neoplasms

Locations

Country	Name	City	State
United States	NYUCancer Institute Clinical Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	identification and development of highly sensitive and specific tumor markers for ovarian cancer		5 years	No