Ovarian Cancer Risk Estimation in Patients With Pelvic Mass

This study has been completed.
Sponsor:
Collaborators:
Advanced Clinical Research Services, LLC
ReSearch Pharmaceutical Services, Inc.
Information provided by:
Fujirebio Diagnostics, Inc.
ClinicalTrials.gov Identifier:
NCT00987649
First received: September 30, 2009
Last updated: February 7, 2011
Last verified: February 2011
  Purpose

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
Adnexal Mass
Ovarian Cancer

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Fujirebio Diagnostics, Inc.:

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 [ Time Frame: Blood draw within 30 days of surgery ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Serum, Plasma, Urine


Enrollment: 512
Study Start Date: October 2009
Study Completion Date: September 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00987649

Locations
United States, California
Scripps Clinic Carmel Valley
San Diego, California, United States, 92130
United States, Colorado
Women's Clinic of Northern Colorado
Fort Collins, Colorado, United States, 80524
United States, Florida
OB/GYN Specialists of the Palm Beaches
Jupiter, Florida, United States, 33458
University of South Florida Medical Center
Tampa, Florida, United States, 33606
United States, Louisiana
Woman's Hospital
Baton Rouge, Louisiana, United States, 70815
United States, New York
Weill Medical College of Cornell University
New York, New York, United States, 10021
United States, North Carolina
New Hanover Regional Medical Center
Wilmington, North Carolina, United States, 28402
United States, Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73110
United States, Pennsylvania
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822
United States, Rhode Island
Women & Infants Hospital Rhode Island
Providence, Rhode Island, United States, 02905
United States, Tennessee
Chattanooga GYN-ONCOLOGY
Chattanooga, Tennessee, United States, 37403
Jackson Clinic
Jackson, Tennessee, United States, 38305
Adams Patterson Gynecology & Obstetrics
Memphis, Tennessee, United States, 38120
Sponsors and Collaborators
Fujirebio Diagnostics, Inc.
Advanced Clinical Research Services, LLC
ReSearch Pharmaceutical Services, Inc.
Investigators
Principal Investigator: Richard Moore, MD, FACOG, FACS Women & Infants Hospital Rhode Island
  More Information

Additional Information:
No publications provided

Responsible Party: Rebecca Simamora, Director Clinical Affairs, Fujirebio Diagnostics, Inc.
ClinicalTrials.gov Identifier: NCT00987649     History of Changes
Other Study ID Numbers: FDI-15
Study First Received: September 30, 2009
Last Updated: February 7, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Fujirebio Diagnostics, Inc.:
pelvic mass
ovarian cancer
adnexal mass
CA125
HE4

Additional relevant MeSH terms:
Ovarian Neoplasms
Adnexal Diseases
Endocrine Gland Neoplasms
Endocrine System Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Gonadal Disorders
Neoplasms
Neoplasms by Site
Ovarian Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on October 21, 2014