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Ovarian Cancer Risk Estimation in Patients With Pelvic Mass

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00987649
Recruitment Status : Completed
First Posted : October 1, 2009
Last Update Posted : February 9, 2011
Advanced Clinical Research Services, LLC
ReSearch Pharmaceutical Services, Inc.
Information provided by:
Fujirebio Diagnostics, Inc.

September 30, 2009
October 1, 2009
February 9, 2011
October 2009
August 2010   (Final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00987649 on ClinicalTrials.gov Archive Site
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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

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.

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Observational Model: Case-Only
Time Perspective: Prospective
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Retention:   Samples Without DNA
Serum, Plasma, Urine
Probability Sample
It is anticipated that approximately 10 general or specialty centers geographically dispersed throughout the United States will be utilized.
  • Adnexal Mass
  • Ovarian Cancer
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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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
September 2010
August 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
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Rebecca Simamora, Director Clinical Affairs, Fujirebio Diagnostics, Inc.
Fujirebio Diagnostics, Inc.
  • Advanced Clinical Research Services, LLC
  • ReSearch Pharmaceutical Services, Inc.
Principal Investigator: Richard Moore, MD, FACOG, FACS Women & Infants Hospital Rhode Island
Fujirebio Diagnostics, Inc.
February 2011