Assess Cancer in Ovarian Tumors With Biomarkers.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00436189
Recruitment Status : Completed
First Posted : February 16, 2007
Last Update Posted : April 30, 2008
Information provided by:
Ciphergen Biosystems

Brief Summary:


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.

Condition or disease Intervention/treatment Phase
Ovarian Tumor Procedure: Blood Draw Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Whole Blood Collection Protocol For Ovarian Assay Clinical Trial In Women With Ovarian Tumors
Study Start Date : February 2007
Primary Completion Date : April 2008
Actual Study Completion Date : April 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer

Primary Outcome Measures :
  1. Proportion of actual ovarian cancer cases among OvaRl positive patients is higher than the proportion of actual ovarian cancer cases among referred patients.

Secondary Outcome Measures :
  1. Evaluate OvaRl assay plus standard clinical practice.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Subject is female and age 18 years or older
  2. 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
  3. Subject signs approved written informed consent prior to any study procedures being performed
  4. Subject must agree to venipuncture
  5. Subject has a documented adnexal tumor with planned surgical intervention

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00436189

United States, Alabama
Clinical Research Consultants
Hoover, Alabama, United States, 35216
United States, Arizona
Women's Health Research
Phoenix, Arizona, United States, 85015
Precision Trials
Phoenix, Arizona, United States, 85032
United States, California
Gynecologic Oncology Associates
Newport Beach, California, United States, 92663
North Coast Women's Care Medical Group Inc
Vista, California, United States, 92083
United States, Connecticut
Farmington Obstetrics and Gynecology Group
Avon, Connecticut, United States, 06001
The GYN Center for Women's Health
Waterbury, Connecticut, United States, 06708
United States, Florida
Florida Hospital Cancer Institute
Orlando, Florida, United States, 32804
OB/GYN Specialists of the Palm Beaches
West Palm Beach, Florida, United States, 33401
United States, Kentucky
University of Kentucky - Whitney Facility
Lexington, Kentucky, United States, 40356-0084
United States, Maine
Maine Medical Center
Scarborough, Maine, United States, 04074
United States, North Carolina
Eastern Carolina Women's Center
New Bern, North Carolina, United States, 28562
United States, Ohio
HWC Women's Research Center
Miamisburg, Ohio, United States, 45342
United States, Oregon
Advanced Clinical Research
Medford, Oregon, United States, 97504
United States, Tennessee
Chattanooga Gyn-Oncology
Chattanooga, Tennessee, United States, 37403
United States, Texas
Austin, Texas, United States, 78746
UT South Western Medical Center at Dallas
Dallas, Texas, United States, 75390
United States, Washington
Tacoma Women's Specialists
Tacoma, Washington, United States, 98405
Sponsors and Collaborators
Ciphergen Biosystems
Study Director: Gillian Crutcher Ciphergen Biosystems, Inc.
Principal Investigator: Fred Ueland, M.D. University of Kentucky
Principal Investigator: Eric Fung, M.D. CSO Ciphergen Biosystems Identifier: NCT00436189     History of Changes
Other Study ID Numbers: OVA-001-C01
First Posted: February 16, 2007    Key Record Dates
Last Update Posted: April 30, 2008
Last Verified: April 2008

Keywords provided by Ciphergen Biosystems:

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