Assess Cancer in Ovarian Tumors With Biomarkers.
This study has been completed.
Sponsor:
Ciphergen Biosystems
Information provided by:
Ciphergen Biosystems
ClinicalTrials.gov Identifier:
NCT00436189
First received: February 13, 2007
Last updated: April 25, 2008
Last verified: April 2008
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Ovarian Tumor |
Procedure: Blood Draw |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | Whole Blood Collection Protocol For Ovarian Assay Clinical Trial In Women With Ovarian Tumors |
Resource links provided by NLM:
Further study details as provided by Ciphergen Biosystems:
Primary Outcome Measures:
- 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:
- Evaluate OvaRl assay plus standard clinical practice.
| Estimated Enrollment: | 1000 |
| Study Start Date: | February 2007 |
| Study Completion Date: | April 2008 |
| Estimated Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00436189
Locations
| United States, Alabama | |
| Clinical Research Consultants | |
| Hoover, Alabama, United States, 35216 | |
| United States, Arizona | |
| Women's Health Research | |
| Phoenix, Arizona, United States, 85015 | |
| Precision Trials | |
| Phoenix, Arizona, United States, 85032 | |
| United States, California | |
| Gynecologic Oncology Associates | |
| Newport Beach, California, United States, 92663 | |
| North Coast Women's Care Medical Group Inc | |
| Vista, California, United States, 92083 | |
| United States, Connecticut | |
| Farmington Obstetrics and Gynecology Group | |
| Avon, Connecticut, United States, 06001 | |
| The GYN Center for Women's Health | |
| Waterbury, Connecticut, United States, 06708 | |
| United States, Florida | |
| Florida Hospital Cancer Institute | |
| Orlando, Florida, United States, 32804 | |
| OB/GYN Specialists of the Palm Beaches | |
| West Palm Beach, Florida, United States, 33401 | |
| United States, Kentucky | |
| University of Kentucky - Whitney Facility | |
| Lexington, Kentucky, United States, 40356-0084 | |
| United States, Maine | |
| Maine Medical Center | |
| Scarborough, Maine, United States, 04074 | |
| United States, North Carolina | |
| Eastern Carolina Women's Center | |
| New Bern, North Carolina, United States, 28562 | |
| United States, Ohio | |
| HWC Women's Research Center | |
| Miamisburg, Ohio, United States, 45342 | |
| United States, Oregon | |
| Advanced Clinical Research | |
| Medford, Oregon, United States, 97504 | |
| United States, Tennessee | |
| Chattanooga Gyn-Oncology | |
| Chattanooga, Tennessee, United States, 37403 | |
| United States, Texas | |
| SWRCC | |
| Austin, Texas, United States, 78746 | |
| UT South Western Medical Center at Dallas | |
| Dallas, Texas, United States, 75390 | |
| United States, Washington | |
| Tacoma Women's Specialists | |
| Tacoma, Washington, United States, 98405 | |
Sponsors and Collaborators
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 |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00436189 History of Changes |
| Other Study ID Numbers: | OVA-001-C01 |
| Study First Received: | February 13, 2007 |
| Last Updated: | April 25, 2008 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Ciphergen Biosystems:
|
Ovarian Cancer Pelvic Mass |
Tumor Adnexal Proteomics |
Additional relevant MeSH terms:
|
Ovarian Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases |
Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders |
ClinicalTrials.gov processed this record on June 18, 2013