Clinical trial NCT00436189: Assess Cancer in Ovarian Tumors With Biomarkers.
Official title: Whole Blood Collection Protocol For Ovarian Assay Clinical Trial In Women With Ovarian Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ovarian Tumor
Keywords: Ovarian
Cancer
Pelvic
Mass
Tumor
Adnexal
Proteomics
Lead sponsor: Ciphergen Biosystems
Sponsor class: INDUSTRY
First posted: 2007-02-16
Enrollment: 1000
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

Eligibility criteria: 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

Primary outcomes:
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 outcomes:
measure: Evaluate OvaRl assay plus standard clinical practice.
Other outcomes:
Locations:
city: Hoover
country: United States
facility: Clinical Research Consultants
state: Alabama
city: Phoenix
country: United States
facility: Women's Health Research
state: Arizona
city: Phoenix
country: United States
facility: Precision Trials
state: Arizona
city: Newport Beach
country: United States
facility: Gynecologic Oncology Associates
state: California
city: Vista
country: United States
facility: North Coast Women's Care Medical Group Inc
state: California
city: Avon
country: United States
facility: Farmington Obstetrics and Gynecology Group
state: Connecticut
city: Waterbury
country: United States
facility: The GYN Center for Women's Health
state: Connecticut
city: Orlando
country: United States
facility: Florida Hospital Cancer Institute
state: Florida
city: West Palm Beach
country: United States
facility: OB/GYN Specialists of the Palm Beaches
state: Florida
city: Lexington
country: United States
facility: University of Kentucky - Whitney Facility
state: Kentucky
city: Scarborough
country: United States
facility: Maine Medical Center
state: Maine
city: New Bern
country: United States
facility: Eastern Carolina Women's Center
state: North Carolina
city: Miamisburg
country: United States
facility: HWC Women's Research Center
state: Ohio
city: Medford
country: United States
facility: Advanced Clinical Research
state: Oregon
city: Chattanooga
country: United States
facility: Chattanooga Gyn-Oncology
state: Tennessee
city: Austin
country: United States
facility: SWRCC
state: Texas
city: Dallas
country: United States
facility: UT South Western Medical Center at Dallas
state: Texas
city: Tacoma
country: United States
facility: Tacoma Women's Specialists
state: Washington
Study officials:
affiliation: Ciphergen Biosystems, Inc.
name: Gillian Crutcher
role: STUDY_DIRECTOR
affiliation: University of Kentucky
name: Fred Ueland, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: CSO Ciphergen Biosystems
name: Eric Fung, M.D.
role: PRINCIPAL_INVESTIGATOR
References: