Ovarian Cancer Risk Estimation in Patients With Pelvic Mass
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
1 other identifier
observational
512
1 country
13
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2009
Shorter than P25 for all trials
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 30, 2009
CompletedFirst Posted
Study publicly available on registry
October 1, 2009
CompletedStudy Start
First participant enrolled
October 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2010
CompletedFebruary 9, 2011
February 1, 2011
10 months
September 30, 2009
February 7, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Blood draw within 30 days of surgery
Eligibility Criteria
It is anticipated that approximately 10 general or specialty centers geographically dispersed throughout the United States will be utilized.
You may qualify if:
- 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
You may not qualify if:
- Previous history of ovarian cancer
- Previous history of bilateral oophorectomy
- Currently known to be pregnant
- Unable to provide informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fujirebio Diagnostics, Inc.lead
- Advanced Clinical Research Services, LLCcollaborator
- ReSearch Pharmaceutical Services, Inc.collaborator
Study Sites (13)
Scripps Clinic Carmel Valley
San Diego, California, 92130, United States
Women's Clinic of Northern Colorado
Fort Collins, Colorado, 80524, United States
OB/GYN Specialists of the Palm Beaches
Jupiter, Florida, 33458, United States
University of South Florida Medical Center
Tampa, Florida, 33606, United States
Woman's Hospital
Baton Rouge, Louisiana, 70815, United States
Weill Medical College of Cornell University
New York, New York, 10021, United States
New Hanover Regional Medical Center
Wilmington, North Carolina, 28402, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73110, United States
Geisinger Medical Center
Danville, Pennsylvania, 17822, United States
Women & Infants Hospital Rhode Island
Providence, Rhode Island, 02905, United States
Chattanooga GYN-ONCOLOGY
Chattanooga, Tennessee, 37403, United States
Jackson Clinic
Jackson, Tennessee, 38305, United States
Adams Patterson Gynecology & Obstetrics
Memphis, Tennessee, 38120, United States
Related Publications (1)
Moore RG, Hawkins DM, Miller MC, Landrum LM, Gajewski W, Ball JJ, Allard WJ, Skates SJ. Combining clinical assessment and the Risk of Ovarian Malignancy Algorithm for the prediction of ovarian cancer. Gynecol Oncol. 2014 Dec;135(3):547-51. doi: 10.1016/j.ygyno.2014.10.017. Epub 2014 Oct 23.
PMID: 25449569DERIVED
Related Links
Biospecimen
Serum, Plasma, Urine
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Richard Moore, MD, FACOG, FACS
Women & Infants Hospital Rhode Island
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 30, 2009
First Posted
October 1, 2009
Study Start
October 1, 2009
Primary Completion
August 1, 2010
Study Completion
September 1, 2010
Last Updated
February 9, 2011
Record last verified: 2011-02