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Ovarian Cancer Risk Estimation in Patients With Pelvic Mass

NCT00987649 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 512

Last updated 2011-02-09

No results posted yet for this study

Summary

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.

Conditions

Sponsors & Collaborators

  • Advanced Clinical Research Services, LLC

    collaborator OTHER

  • ReSearch Pharmaceutical Services, Inc.

    collaborator INDUSTRY

  • Fujirebio Diagnostics, Inc.

    lead INDUSTRY

Principal Investigators

  • Richard Moore, MD, FACOG, FACS · Women & Infants Hospital Rhode Island

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2010-08-31
Completion
2010-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00987649 on ClinicalTrials.gov