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Clinical Trials/NCT01466049
NCT01466049
Completed
Not Applicable

Evaluation of New Biomarker Assays in Ovarian Cancer Patients Presenting to a Generalist With an Adnexal Mass

Fujirebio Diagnostics, Inc.2 sites in 1 country280 target enrollmentDecember 2011
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ConditionsAdnexal Mass

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Adnexal Mass
Sponsor
Fujirebio Diagnostics, Inc.
Enrollment
280
Locations
2
Primary Endpoint
Evaluate novel biomarkers for patients with an adnexal mass
Status
Completed
Last Updated
11 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 2011
End Date
March 2014
Last Updated
11 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility 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

Outcomes

Primary Outcomes

Evaluate novel biomarkers for patients with an adnexal mass

Time Frame: observational studies

Study Sites (2)

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