Ovarian Cancer Risk Estimation in Patients With Pelvic Mass

This study has been completed.

First Received on September 30, 2009. Last Updated on February 7, 2011 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:	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:

Genetics Home Reference related topics: Marfan syndrome

MedlinePlus related topics: Cancer Ovarian Cancer

U.S. FDA Resources

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

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:

Information related to Fujirebio Diagnostics, Inc. This link exits the ClinicalTrials.gov site

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
Marfan Syndrome
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders

Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Abnormalities, Multiple
Congenital Abnormalities
Genetic Diseases, Inborn
Connective Tissue Diseases

ClinicalTrials.gov processed this record on February 09, 2012