Ovarian Cancer Risk Estimation in Patients With Pelvic Mass

Sponsor

Fujirebio Diagnostics, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT00987649

Collaborator

Advanced Clinical Research Services, LLC (Other), ReSearch Pharmaceutical Services, Inc. (Industry)

512

Enrollment

Locations

Duration (Months)

39.4

Patients Per Site

3.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Adnexal Mass Ovarian Cancer

Study Design

Study Type:

Observational

Actual Enrollment :

512 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

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 Start Date :

Oct 1, 2009

Actual Primary Completion Date :

Aug 1, 2010

Actual Study Completion Date :

Sep 1, 2010

Outcome Measures

Primary Outcome Measures

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

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Scripps Clinic Carmel Valley	San Diego	California	United States	92130
2	Women's Clinic of Northern Colorado	Fort Collins	Colorado	United States	80524
3	OB/GYN Specialists of the Palm Beaches	Jupiter	Florida	United States	33458
4	University of South Florida Medical Center	Tampa	Florida	United States	33606
5	Woman's Hospital	Baton Rouge	Louisiana	United States	70815
6	Weill Medical College of Cornell University	New York	New York	United States	10021
7	New Hanover Regional Medical Center	Wilmington	North Carolina	United States	28402
8	University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma	United States	73110
9	Geisinger Medical Center	Danville	Pennsylvania	United States	17822
10	Women & Infants Hospital Rhode Island	Providence	Rhode Island	United States	02905
11	Chattanooga GYN-ONCOLOGY	Chattanooga	Tennessee	United States	37403
12	Jackson Clinic	Jackson	Tennessee	United States	38305
13	Adams Patterson Gynecology & Obstetrics	Memphis	Tennessee	United States	38120