Assess Cancer in Ovarian Tumors With Biomarkers.

NCT00436189 | Completed

• 1 other identifier: OVA-001-C01
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 18

Brief Summary

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.

Conditions

Ovarian Tumor

Keywords

Ovarian; Cancer; Pelvic; Mass; Tumor; Adnexal; Proteomics

Outcome Measures

Primary Outcomes (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 Outcomes (1)

• Evaluate OvaRl assay plus standard clinical practice.

Interventions

Blood Draw PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Ciphergen Biosystems: lead

Study Sites (18)

Clinical Research Consultants

Hoover, Alabama, 35216, United States

Location

Women's Health Research

Phoenix, Arizona, 85015, United States

Location

Precision Trials

Phoenix, Arizona, 85032, United States

Location

Gynecologic Oncology Associates

Newport Beach, California, 92663, United States

Location

North Coast Women's Care Medical Group Inc

Vista, California, 92083, United States

Location

Farmington Obstetrics and Gynecology Group

Avon, Connecticut, 06001, United States

Location

The GYN Center for Women's Health

Waterbury, Connecticut, 06708, United States

Location

Florida Hospital Cancer Institute

Orlando, Florida, 32804, United States

Location

OB/GYN Specialists of the Palm Beaches

West Palm Beach, Florida, 33401, United States

Location

University of Kentucky - Whitney Facility

Lexington, Kentucky, 40356-0084, United States

Location

Maine Medical Center

Scarborough, Maine, 04074, United States

Location

Eastern Carolina Women's Center

New Bern, North Carolina, 28562, United States

Location

HWC Women's Research Center

Miamisburg, Ohio, 45342, United States

Location

Advanced Clinical Research

Medford, Oregon, 97504, United States

Location

Chattanooga Gyn-Oncology

Chattanooga, Tennessee, 37403, United States

Location

SWRCC

Austin, Texas, 78746, United States

Location

UT South Western Medical Center at Dallas

Dallas, Texas, 75390, United States

Location

Tacoma Women's Specialists

Tacoma, Washington, 98405, United States

Location

MeSH Terms

Conditions

Ovarian Neoplasms; Neoplasms; Arachnodactyly

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Limb Deformities, Congenital; Musculoskeletal Abnormalities; Musculoskeletal Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Gillian Crutcher

  Ciphergen Biosystems, Inc.

  STUDY DIRECTOR

• Fred Ueland, M.D.

  University of Kentucky

  PRINCIPAL INVESTIGATOR

• Eric Fung, M.D.

  CSO Ciphergen Biosystems

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 13, 2007
• First Posted: February 16, 2007
• Study Start: February 1, 2007
• Primary Completion: April 1, 2008
• Study Completion: April 1, 2008
• Last Updated: April 30, 2008

Record last verified: 2008-04

Locations

US (18)