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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1000

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ciphergen Biosystems

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2007

Primary Completion

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2008

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2008

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 13, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 15, 2007

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 16, 2007

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 30, 2008

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 25, 2008

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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