New Biomarkers Evaluating Ovarian Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01466049
Recruitment Status : Completed
First Posted : November 7, 2011
Last Update Posted : August 5, 2014
Information provided by (Responsible Party):
Fujirebio Diagnostics, Inc.

Brief Summary:
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 or disease
Adnexal Mass

Study Type : Observational
Actual Enrollment : 280 participants
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
Study Start Date : December 2011
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer

Primary Outcome Measures :
  1. Evaluate novel biomarkers for patients with an adnexal mass [ Time Frame: observational studies ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01466049

United States, North Carolina
New Hanover Regional Medical Center
Wilmington, North Carolina, United States, 28402
United States, Oklahoma
University of Oklahoma
Oklahoma City, Oklahoma, United States, 73110
Sponsors and Collaborators
Fujirebio Diagnostics, Inc.
Study Director: Diana Dickson Fujirebio Diagnostics, Inc.

Responsible Party: Fujirebio Diagnostics, Inc. Identifier: NCT01466049     History of Changes
Other Study ID Numbers: FDI-35
First Posted: November 7, 2011    Key Record Dates
Last Update Posted: August 5, 2014
Last Verified: August 2014

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

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