New Biomarkers Evaluating Ovarian Cancer

This study is currently recruiting participants.
Verified November 2013 by Fujirebio Diagnostics, Inc.
Sponsor:
Information provided by (Responsible Party):
Fujirebio Diagnostics, Inc.
ClinicalTrials.gov Identifier:
NCT01466049
First received: November 3, 2011
Last updated: November 8, 2013
Last verified: November 2013
  Purpose

The purpose of this study is to evaluate new biomarkers for patients presenting to a physician for surgery to remove a mass in their pelvis and to continue to evaluate these types of patients using the ROMA algorithm for post-market benefits.


Condition
Adnexal Mass

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of New Biomarker Assays in Ovarian Cancer Patients Presenting to a Generalist With an Adnexal Mass

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Evaluate novel biomarkers for patients with an adnexal mass [ Time Frame: observational studies ] [ Designated as safety issue: No ]

Estimated Enrollment: 500
Study Start Date: December 2011
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: December 2015 (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

Women with an adnexal mass, presenting to a general surgeon or obstetrician/ gynecologist at a general or specialty center within the United States, for whom a decision to proceed with surgery to remove the mass has been made.

Criteria

Inclusion Criteria:

  • Female, age 18 years or older
  • Adnexal mass present documented by imaging
  • Scheduled to undergo surgery based on a finding of adnexal mass
  • Able 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: NCT01466049

Contacts
Contact: Katherine L Falcone 610.240.3864 falconek@fdi.com
Contact: Rachel Radwan 610.240.3822 radwanr@fdi.com

Locations
United States, North Carolina
New Hanover Regional Medical Center Recruiting
Wilmington, North Carolina, United States, 28402
Contact: Walter Gajewski, MD    910-949-2862      
Principal Investigator: Walter Gajewski, MD         
United States, Oklahoma
University of Oklahoma Completed
Oklahoma City, Oklahoma, United States, 73110
Sponsors and Collaborators
Fujirebio Diagnostics, Inc.
Investigators
Study Director: Diana Dickson Fujirebio Diagnostics, Inc.
  More Information

No publications provided

Responsible Party: Fujirebio Diagnostics, Inc.
ClinicalTrials.gov Identifier: NCT01466049     History of Changes
Other Study ID Numbers: FDI-35
Study First Received: November 3, 2011
Last Updated: November 8, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Fujirebio Diagnostics, Inc.:
Ovarian Cancer
Adnexal Mass
Pelvic Mass

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

ClinicalTrials.gov processed this record on April 14, 2014