Ovarian Cancer Risk Estimation in Patients With Pelvic Mass
This study has been completed.
Sponsor:
Fujirebio Diagnostics, Inc.
Collaborators:
Advanced Clinical Research Services, LLC
ReSearch Pharmaceutical Services, Inc.
Information provided by:
Fujirebio Diagnostics, Inc.
ClinicalTrials.gov Identifier:
NCT00987649
First received: September 30, 2009
Last updated: February 7, 2011
Last verified: February 2011
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Purpose
The purpose of this study is to determine whether the Risk of Ovarian Cancer Algorithm (ROMA) is effective in the determination of a woman's risk of cancer when she is scheduled to have surgery to remove a pelvic mass.
After Informed Consent is obtained, an Initial Cancer Risk Assessment will be made. A blood sample will be collected within 30 days of the surgical procedure. Results of the surgical procedure will be collected and analyzed against the CA125 and HE4 results used in the calculation of the ROMA.
| Condition |
|---|
|
Adnexal Mass Ovarian Cancer |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | Evaluation of CA125 and HE4 Assays to Estimate the Risk of Ovarian Cancer in Patients Presenting to a General Surgeon or Obstetrician/Gynecologist With an Adnexal Mass |
Resource links provided by NLM:
Further study details as provided by Fujirebio Diagnostics, Inc.:
Primary Outcome Measures:
- 1. A statistically higher number of cancer patients are correctly assigned by the combination of Initial Cancer Risk assessment and positive ROMA test result than by Initial Cancer Risk assessment alone [ Time Frame: Blood draw within 30 days of surgery ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples Without DNA
Serum, Plasma, Urine
| Enrollment: | 512 |
| Study Start Date: | October 2009 |
| Study Completion Date: | September 2010 |
| Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
It is anticipated that approximately 10 general or specialty centers geographically dispersed throughout the United States will be utilized.
Criteria
Inclusion Criteria:
- Female, age ≥ 18 years
- Adnexal mass present documented by imaging
- Scheduled to undergo surgery based on a finding of adnexal mass (defined as a simple, complex or a solid ovarian cyst/or any mass in pelvis)
- Able to understand and willing to provide Informed Consent
Exclusion Criteria:
- Previous history of ovarian cancer
- Previous history of bilateral oophorectomy
- Currently known to be pregnant
- Unable to provide informed consent
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00987649
Locations
| United States, California | |
| Scripps Clinic Carmel Valley | |
| San Diego, California, United States, 92130 | |
| United States, Colorado | |
| Women's Clinic of Northern Colorado | |
| Fort Collins, Colorado, United States, 80524 | |
| United States, Florida | |
| OB/GYN Specialists of the Palm Beaches | |
| Jupiter, Florida, United States, 33458 | |
| University of South Florida Medical Center | |
| Tampa, Florida, United States, 33606 | |
| United States, Louisiana | |
| Woman's Hospital | |
| Baton Rouge, Louisiana, United States, 70815 | |
| United States, New York | |
| Weill Medical College of Cornell University | |
| New York, New York, United States, 10021 | |
| United States, North Carolina | |
| New Hanover Regional Medical Center | |
| Wilmington, North Carolina, United States, 28402 | |
| United States, Oklahoma | |
| University of Oklahoma Health Sciences Center | |
| Oklahoma City, Oklahoma, United States, 73110 | |
| United States, Pennsylvania | |
| Geisinger Medical Center | |
| Danville, Pennsylvania, United States, 17822 | |
| United States, Rhode Island | |
| Women & Infants Hospital Rhode Island | |
| Providence, Rhode Island, United States, 02905 | |
| United States, Tennessee | |
| Chattanooga GYN-ONCOLOGY | |
| Chattanooga, Tennessee, United States, 37403 | |
| Jackson Clinic | |
| Jackson, Tennessee, United States, 38305 | |
| Adams Patterson Gynecology & Obstetrics | |
| Memphis, Tennessee, United States, 38120 | |
Sponsors and Collaborators
Fujirebio Diagnostics, Inc.
Advanced Clinical Research Services, LLC
ReSearch Pharmaceutical Services, Inc.
Investigators
| Principal Investigator: | Richard Moore, MD, FACOG, FACS | Women & Infants Hospital Rhode Island |
More Information
Additional Information:
No publications provided
| Responsible Party: | Rebecca Simamora, Director Clinical Affairs, Fujirebio Diagnostics, Inc. |
| ClinicalTrials.gov Identifier: | NCT00987649 History of Changes |
| Other Study ID Numbers: | FDI-15 |
| Study First Received: | September 30, 2009 |
| Last Updated: | February 7, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Fujirebio Diagnostics, Inc.:
|
pelvic mass ovarian cancer adnexal mass CA125 HE4 |
Additional relevant MeSH terms:
|
Ovarian Neoplasms Marfan Syndrome Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders |
Bone Diseases, Developmental Bone Diseases Musculoskeletal Diseases Heart Defects, Congenital Cardiovascular Abnormalities Cardiovascular Diseases Heart Diseases Abnormalities, Multiple Congenital Abnormalities Genetic Diseases, Inborn Connective Tissue Diseases |
ClinicalTrials.gov processed this record on May 16, 2013