Diagnostic Accuracy of Fine Needle Aspiration in Parotid Tumors

Early Phase 1

• Conditions: Parotid Gland Neoplasms
• Interventions: Procedure: aspiration biopsy

• Registration Number: NCT00534612
• Lead Sponsor: National Institute of Cancerología

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 Description

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.

Study Timeline

• Status Verified: 2003-01
• Study Start: 2003-01
• Study First Submitted: 2007-09-21
• Study First Submitted QC: 2007-09-24
• Last Update Submitted: 2007-09-24
• Study First Posted: 2007-09-26
• Last Update Posted: 2007-09-26
• Study Completion: 2007-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Consecutive patients with parotid gland masses

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	aspiration biopsy	fine needle aspiration biopsy of the parotid gland mass

Primary Outcome Measures

Name	Time	Method
Diagnosis of malignancy	three years

Secondary Outcome Measures

Name	Time	Method
Specific histopathologic diagnosis	three years

Trial Locations

Locations (1)

National Cancer Institute; 🇲🇽 Mexico, D.f:, Mexico