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Ovarian Cancer Risk Estimation in Patients With Pelvic Mass
This study is currently recruiting participants.
Verified by Fujirebio Diagnostics, Inc., November 2009
First Received: September 30, 2009   Last Updated: November 6, 2009   History of Changes
Sponsor: Fujirebio Diagnostics, Inc.
Collaborators: Advanced Clinical Research Services, LLC
ReSearch Pharmaceutical Services, Inc.
Information provided by: Fujirebio Diagnostics, Inc.
ClinicalTrials.gov Identifier: NCT00987649
  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: Case-Only, 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

Biospecimen Description:

Serum, Plasma, Urine


Estimated Enrollment: 525
Study Start Date: October 2009
Estimated Study Completion Date: May 2010
Estimated Primary Completion Date: April 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00987649

Contacts
Contact: Paula S Renneisen 610.240.3927 renneisenp@fdi.com
Contact: Katherine Falcone 610.240.3864 falconek@fdi.com

Locations
United States, California
Scripps Clinic Carmel Valley Recruiting
San Diego, California, United States, 92130
Contact: Nancy Giovanetty, CMA, CRC     858-764-3023     giovanetty.nancy@scrippshealth.org    
Principal Investigator: Bruce S Kahn, MD, FACOG            
United States, Florida
OB/GYN Specialists of the Palm Beaches Not yet recruiting
Jupiter, Florida, United States, 33458
Contact: Jennifer Schindel, RN, CCRC     561-802-5331     jschindel@ogspb.com    
Contact: Joanne Lutz, RN, CCRC     561.802.5331     jlutz@ogspb.com    
Principal Investigator: Donna M Pinelli, MD            
University of South Florida Medical Center Not yet recruiting
Tampa, Florida, United States, 33606
Contact: Caroline Young, MSN, ARNP     813-259-8685     cayoung@health.usf.edu    
Principal Investigator: Anna Parsons, MD            
United States, Louisiana
Woman's Hospital Not yet recruiting
Baton Rouge, Louisiana, United States, 70815
Contact: Shonta' Wallace     225-231-5656     SHONTA.WALLACE@womans.org    
Principal Investigator: Beverly Ogden, MD            
United States, North Carolina
New Hanover Regional Medical Center Not yet recruiting
Wilmington, North Carolina, United States, 28402
Contact: Lynette Racco, OCN     910-343-4075     Lynette.Racco@nhrmc.org    
Contact: Monique Harris     (910) 343-7641     Monique.Harris@nhrmc.org    
Principal Investigator: Walter Gajewski, MD,            
United States, Pennsylvania
Geisinger Medical Center Not yet recruiting
Danville, Pennsylvania, United States, 17822
Contact: Kristina Evans, MPH     570-214-9553     ksevans@geisinger.edu    
Contact: Eric Wagner         eswagner@geisinger.edu    
Principal Investigator: John Nash, MD            
United States, Rhode Island
Women & Infants Hospital Rhode Island Recruiting
Providence, Rhode Island, United States, 02905
Contact: Wendy B Young, MSN, NP-C, OCN     401.270.6221     wyoung@wihri.org    
Contact: Janet Mari, RN, CCRC     401.274.1122 ext 2843     jmari@wihri.org    
Principal Investigator: Paul DiSilvestro, MD            
United States, Tennessee
Adams Patterson Gynecology & Obstetrics Recruiting
Memphis, Tennessee, United States, 38120
Contact: Jennifer Hamil, RN     901-507-1014     Jennifer.Hamil@scresearch.net    
Principal Investigator: Todd Chappell, MD            
Jackson Clinic Recruiting
Jackson, Tennessee, United States, 38305
Contact: Dawn Coleman     731-660-8320     dawn.coleman@scresearch.net    
Principal Investigator: John J Ball, MD            
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: Fujirebio Diagnostics, Inc. ( Rebecca Simamora, Director Clinical Affairs )
Study ID Numbers: FDI-15
Study First Received: September 30, 2009
Last Updated: November 6, 2009
ClinicalTrials.gov Identifier: NCT00987649     History of Changes
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:
Genital Diseases, Female
Neoplasms
Neoplasms by Site
Ovarian Neoplasms
Gonadal Disorders
Genital Neoplasms, Female
Endocrine System Diseases
Urogenital Neoplasms
Ovarian Diseases
Adnexal Diseases
Endocrine Gland Neoplasms

ClinicalTrials.gov processed this record on February 08, 2010