Ovarian Cancer Risk Estimation in Patients With Pelvic Mass

February 7, 2011 updated by: Fujirebio Diagnostics, Inc.

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

512

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- California
  - San Diego, California, United States, 92130
    - Scripps Clinic Carmel Valley
- Colorado
  - Fort Collins, Colorado, United States, 80524
    - Women's Clinic of Northern Colorado
- Florida
  - Jupiter, Florida, United States, 33458
    - OB/GYN Specialists of the Palm Beaches
  - Tampa, Florida, United States, 33606
    - University Of South Florida Medical Center
- Louisiana
  - Baton Rouge, Louisiana, United States, 70815
    - Woman's Hospital
- New York
  - New York, New York, United States, 10021
    - Weill Medical College of Cornell University
- North Carolina
  - Wilmington, North Carolina, United States, 28402
    - New Hanover Regional Medical Center
- Oklahoma
  - Oklahoma City, Oklahoma, United States, 73110
    - University of Oklahoma Health Sciences Center
- Pennsylvania
  - Danville, Pennsylvania, United States, 17822
    - Geisinger Medical Center
- Rhode Island
  - Providence, Rhode Island, United States, 02905
    - Women & Infants Hospital Rhode Island
- Tennessee
  - Chattanooga, Tennessee, United States, 37403
    - Chattanooga GYN-Oncology
  - Jackson, Tennessee, United States, 38305
    - Jackson Clinic
  - Memphis, Tennessee, United States, 38120
    - Adams Patterson Gynecology & Obstetrics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

Female

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: Case-Only
Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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	Blood draw within 30 days of surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fujirebio Diagnostics, Inc.

Collaborators

Advanced Clinical Research Services, LLC

ReSearch Pharmaceutical Services, Inc.

Investigators

Principal Investigator: Richard Moore, MD, FACOG, FACS, Women & Infants Hospital Rhode Island

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.

Helpful Links

Information related to Fujirebio Diagnostics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Actual)

August 1, 2010

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

September 30, 2009

First Submitted That Met QC Criteria