Ovarian Cancer Risk Estimation in Patients With Pelvic Mass

Ovarian Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00987649
• Other study ID #: FDI-15
• Status: Completed
• Phase: N/A
• First received: September 30, 2009
• Last updated: February 7, 2011
• Start date: October 2009
• Est. completion date: September 2010

Study information

• Verified date: February 2011
• Source: Fujirebio Diagnostics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 512
• Est. completion date: September 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Adnexal Mass
• Ovarian Cancer
• Ovarian Neoplasms

Locations

Country	Name	City	State
United States	Woman's Hospital	Baton Rouge	Louisiana
United States	Chattanooga GYN-ONCOLOGY	Chattanooga	Tennessee
United States	Geisinger Medical Center	Danville	Pennsylvania
United States	Women's Clinic of Northern Colorado	Fort Collins	Colorado
United States	Jackson Clinic	Jackson	Tennessee
United States	OB/GYN Specialists of the Palm Beaches	Jupiter	Florida
United States	Adams Patterson Gynecology & Obstetrics	Memphis	Tennessee
United States	Weill Medical College of Cornell University	New York	New York
United States	University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma
United States	Women & Infants Hospital Rhode Island	Providence	Rhode Island
United States	Scripps Clinic Carmel Valley	San Diego	California
United States	University of South Florida Medical Center	Tampa	Florida
United States	New Hanover Regional Medical Center	Wilmington	North Carolina

Sponsors (3)

Lead Sponsor	Collaborator
Fujirebio Diagnostics, Inc.	Advanced Clinical Research Services, LLC, ReSearch Pharmaceutical Services, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No

External Links

•   Information related to Fujirebio Diagnostics, Inc.