Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
1000 participants
INTERVENTIONAL
2007-02-28
2008-04-30
Brief Summary
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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.
Detailed Description
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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
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
DIAGNOSTIC
NONE
Interventions
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Blood Draw
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
FEMALE
No
Sponsors
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Ciphergen Biosystems
INDUSTRY
Principal Investigators
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Gillian Crutcher
Role: STUDY_DIRECTOR
Ciphergen Biosystems, Inc.
Fred Ueland, M.D.
Role: PRINCIPAL_INVESTIGATOR
University of Kentucky
Eric Fung, M.D.
Role: PRINCIPAL_INVESTIGATOR
CSO Ciphergen Biosystems
Locations
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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
Countries
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Other Identifiers
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OVA-001-C01
Identifier Type: -
Identifier Source: org_study_id