Clinical Trial: Diagnostic Accuracy of Fine Needle Aspiration in Parotid Tumors

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Accuracy of Fine Needle Aspiration Biopsy in the Pre-Operative Diagnosis of Malignancy in Patients With Parotid Gland Masses

Brief Summary: Liberal use of fine needle aspiration biopsy of parotid gland masses is controversial. All information regarding this procedure has been retrospective. Our objective is to evaluate prospectively the diagnostic accuracy of the test, alone and when associated to clinical and/or radiologic data.

Detailed Summary:

This is a prospective diagnostic test study. Inclusion criteria are all consecutive patients with parotid gland masses referred for treatment at our center, from January 2003 to December 2007.

The gold standard for the diagnosis of malignancy is the surgical pathology report of the parotidectomy specimen.

Cytologist and pathologist will be blind. Diagnostic accuracy is determinded by Bayesian analysis.

Sponsor: National Institute of Cancerología

Current Primary Outcome: Diagnosis of malignancy [ Time Frame: three years ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Specific histopathologic diagnosis [ Time Frame: three years ]

Original Secondary Outcome: Same as current

Information By: National Institute of Cancerología

Dates:
Date Received: September 21, 2007
Date Started: January 2003
Date Completion: December 2007
Last Updated: September 24, 2007
Last Verified: January 2003