Assess Cancer in Ovarian Tumors With Biomarkers.

April 25, 2008 updated by: Ciphergen Biosystems

Whole Blood Collection Protocol For Ovarian Assay Clinical Trial In Women With Ovarian Tumors

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Study Design This is a multi-center study including low and high prevalence ovarian cancer sites. The sites are representative of all institutions where potential ovarian tumor subjects will undergo a gynecological examination with radiological exam prior to surgical intervention. A blood specimen will be taken once only from enrolled subjects. This blood specimen will be used in the evaluation of the OvaRl test to identify subjects with ovarian cancer from within a population of women with a documented ovarian mass and planned surgical intervention.

Expected Total Enrollment: Up to 1000 subjects with a documented ovarian mass Study Start: February 2007

Study Details:

Study Population:

Female subjects over the age of 18 with an ovarian tumor with planned surgical intervention will be enrolled at up to 40 sites. The sites will be demographically mixed to include, for example, large and small medical centers (universities/community hospitals), small gynecology/obstetrics groups, gynecology/oncology practices, and HMO groups.

It is anticipated up to 1000 subjects will enroll. This population will exclude minors, pregnant women, or patients with a history of malignancy in the last 10 years, with the exception of a non-melanoma skin cancer.

You will only be asked to participate in this study if you have a documented mass or tumor in your ovarian area. The Ciphergen OvaR1 assay is a proteomics-based blood test that assists the physician to determine whether the documented tumor is cancer or benign (non-cancer). This is not a necessary part of your treatment. You are already scheduled to have an operation to remove this tumor, which makes you eligible for this trial. If you agree to participate you will be one of up to 1000 people to do so.

Once you are scheduled for surgery, you will be asked to provide a blood specimen once only. The blood sample will be prior to your surgery. The sample will consist of 30-50 ml of blood (about 2-3 tablespoons) drawn from a vein in your arm. The blood specimen will be processed and blood serum specimens stored, then tested with the OvaRI assay which looks at proteomic patterns indicative of cancer or non-cancer. Your serum specimens will be assigned a coded identification number to protect your privacy. Your research blood will be drawn at the time of your routine pre-operative blood work visit or at the time of surgery depending on scheduling. The only risks and potential discomforts outside of your surgery are associated with the blood draw.

The primary principal investigator in charge of this study is Frederick R. Ueland, M.D., of the University of Kentucky.

You will not receive any personal benefit from taking part in this study. However, the information obtained from your participation may potentially benefit other patients in the future by providing helpful information about proteomic patterns connected with ovarian tumors.

Subject Participation Eligibility:

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 ovarian 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

Study Type

Interventional

Enrollment (Anticipated)

1000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Hoover, Alabama, United States, 35216
        • Clinical Research Consultants
    • Arizona
      • Phoenix, Arizona, United States, 85015
        • Women's Health Research
      • Phoenix, Arizona, United States, 85032
        • Precision Trials
    • California
      • Newport Beach, California, United States, 92663
        • Gynecologic Oncology Associates
      • Vista, California, United States, 92083
        • North Coast Women's Care Medical Group Inc
    • Connecticut
      • Avon, Connecticut, United States, 06001
        • Farmington Obstetrics and Gynecology Group
      • Waterbury, Connecticut, United States, 06708
        • The GYN Center for Women's Health
    • Florida
      • Orlando, Florida, United States, 32804
        • Florida Hospital Cancer Institute
      • West Palm Beach, Florida, United States, 33401
        • OB/GYN Specialists of the Palm Beaches
    • Kentucky
      • Lexington, Kentucky, United States, 40356-0084
        • University of Kentucky - Whitney Facility
    • Maine
      • Scarborough, Maine, United States, 04074
        • Maine Medical Center
    • North Carolina
      • New Bern, North Carolina, United States, 28562
        • Eastern Carolina Women's Center
    • Ohio
      • Miamisburg, Ohio, United States, 45342
        • HWC Women's Research Center
    • Oregon
      • Medford, Oregon, United States, 97504
        • Advanced Clinical Research
    • Tennessee
      • Chattanooga, Tennessee, United States, 37403
        • Chattanooga GYN-Oncology
    • Texas
      • Austin, Texas, United States, 78746
        • SWRCC
      • Dallas, Texas, United States, 75390
        • UT South Western Medical Center at Dallas
    • Washington
      • Tacoma, Washington, United States, 98405
        • Tacoma Women's Specialists

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
Evaluate OvaRl assay plus standard clinical practice.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ciphergen Biosystems

Investigators

  • 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2007

Primary Completion

April 1, 2008

Study Completion (Actual)

April 1, 2008

Study Registration Dates

First Submitted

February 13, 2007

First Submitted That Met QC Criteria

February 15, 2007

First Posted (Estimate)

February 16, 2007

Study Record Updates

Last Update Posted (Estimate)

April 30, 2008

Last Update Submitted That Met QC Criteria

April 25, 2008

Last Verified

April 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OVA-001-C01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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