Ovarian Cancer Risk Estimation in Patients With Pelvic Mass
NCT ID: NCT00987649
Last Updated: 2011-02-09
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
512 participants
OBSERVATIONAL
2009-10-31
2010-09-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* 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 bilateral oophorectomy
* Currently known to be pregnant
* Unable to provide informed consent
18 Years
FEMALE
No
Sponsors
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Advanced Clinical Research Services, LLC
OTHER
ReSearch Pharmaceutical Services, Inc.
INDUSTRY
Fujirebio Diagnostics, Inc.
INDUSTRY
Responsible Party
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Fujirebio Diagnostics, Inc.
Principal Investigators
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Richard Moore, MD, FACOG, FACS
Role: PRINCIPAL_INVESTIGATOR
Women & Infants Hospital Rhode Island
Locations
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Scripps Clinic Carmel Valley
San Diego, California, United States
Women's Clinic of Northern Colorado
Fort Collins, Colorado, United States
OB/GYN Specialists of the Palm Beaches
Jupiter, Florida, United States
University of South Florida Medical Center
Tampa, Florida, United States
Woman's Hospital
Baton Rouge, Louisiana, United States
Weill Medical College of Cornell University
New York, New York, United States
New Hanover Regional Medical Center
Wilmington, North Carolina, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Geisinger Medical Center
Danville, Pennsylvania, United States
Women & Infants Hospital Rhode Island
Providence, Rhode Island, United States
Chattanooga GYN-ONCOLOGY
Chattanooga, Tennessee, United States
Jackson Clinic
Jackson, Tennessee, United States
Adams Patterson Gynecology & Obstetrics
Memphis, Tennessee, United States
Countries
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References
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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.
Related Links
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Information related to Fujirebio Diagnostics, Inc.
Other Identifiers
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FDI-15
Identifier Type: -
Identifier Source: org_study_id
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