Clinical trial NCT00987649: Ovarian Cancer Risk Estimation in Patients With Pelvic Mass
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Adnexal Mass
Ovarian Cancer
Keywords: pelvic mass
ovarian cancer
adnexal mass
CA125
HE4
Lead sponsor: Fujirebio Diagnostics, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Advanced Clinical Research Services, LLC
name: ReSearch Pharmaceutical Services, Inc.
First posted: 2009-10-01
Enrollment: 512
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.


Eligibility 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

Primary outcomes:
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
timeFrame: Blood draw within 30 days of surgery
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Scripps Clinic Carmel Valley
state: California
city: Fort Collins
country: United States
facility: Women's Clinic of Northern Colorado
state: Colorado
city: Jupiter
country: United States
facility: OB/GYN Specialists of the Palm Beaches
state: Florida
city: Tampa
country: United States
facility: University of South Florida Medical Center
state: Florida
city: Baton Rouge
country: United States
facility: Woman's Hospital
state: Louisiana
city: New York
country: United States
facility: Weill Medical College of Cornell University
state: New York
city: Wilmington
country: United States
facility: New Hanover Regional Medical Center
state: North Carolina
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Sciences Center
state: Oklahoma
city: Danville
country: United States
facility: Geisinger Medical Center
state: Pennsylvania
city: Providence
country: United States
facility: Women & Infants Hospital Rhode Island
state: Rhode Island
city: Chattanooga
country: United States
facility: Chattanooga GYN-ONCOLOGY
state: Tennessee
city: Jackson
country: United States
facility: Jackson Clinic
state: Tennessee
city: Memphis
country: United States
facility: Adams Patterson Gynecology & Obstetrics
state: Tennessee
Study officials:
affiliation: Women & Infants Hospital Rhode Island
name: Richard Moore, MD, FACOG, FACS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.