Assess Cancer in Ovarian Tumors With Biomarkers.

Completed · Not applicable

Conditions studied: Ovarian Tumor

In brief

Purpose The OvaRI assay clinical trial is directed at evaluating a novel proteomics-based blood test. This test is for a physician to use towards differentiating benign from malignant ovarian tumors prior to surgical intervention. Tools that can better triage women with an ovarian tumor are needed. It has been shown that women with ovarian cancer who are referred to gynecologic oncologists have better outcomes. The primary objective of this study is to demonstrate that the OvaRl assay (test) improves the preoperative identification of ovarian cancer in patients with a ovarian tumor.

Key facts

Study ID

NCT00436189

Run by

Ciphergen Biosystems

People needed

1000

Starts

2007-02-01

Expected to finish

2008-04-01

Last updated by the study team

2008-04-30

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Subject is female and age 18 years or older
• Subject has a level of understanding sufficient to agree to all tests required by the protocol, must be considered reliable and must be able to cooperate with study procedures
• Subject signs approved written informed consent prior to any study procedures being performed
• Subject must agree to venipuncture
• Subject has a documented adnexal tumor with planned surgical intervention

You may not qualify if…

• Women under age 18
• No planned surgical intervention
• Decline phlebotomy
• Diagnosis of malignancy in the last 10 years, with the exception of a non-melanoma skin cancer

Where it is running

• Clinical Research Consultants — Hoover, Alabama, United States
• Women's Health Research — Phoenix, Arizona, United States
• Precision Trials — Phoenix, Arizona, United States
• Gynecologic Oncology Associates — Newport Beach, California, United States
• North Coast Women's Care Medical Group Inc — Vista, California, United States
• Farmington Obstetrics and Gynecology Group — Avon, Connecticut, United States
• The GYN Center for Women's Health — Waterbury, Connecticut, United States
• Florida Hospital Cancer Institute — Orlando, Florida, United States
• OB/GYN Specialists of the Palm Beaches — West Palm Beach, Florida, United States
• University of Kentucky - Whitney Facility — Lexington, Kentucky, United States
• Maine Medical Center — Scarborough, Maine, United States
• Eastern Carolina Women's Center — New Bern, North Carolina, United States
• HWC Women's Research Center — Miamisburg, Ohio, United States
• Advanced Clinical Research — Medford, Oregon, United States
• Chattanooga Gyn-Oncology — Chattanooga, Tennessee, United States
• SWRCC — Austin, Texas, United States
• UT South Western Medical Center at Dallas — Dallas, Texas, United States
• Tacoma Women's Specialists — Tacoma, Washington, United States

Full record on ClinicalTrials.gov

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