Diagnostic Accuracy of Fine Needle Aspiration in Parotid Tumors

Parotid Gland Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00534612
• Other study ID #: 006/038/CCI
• Status: Recruiting
• Phase: Phase 0
• First received: September 21, 2007
• Last updated: September 24, 2007
• Start date: January 2003
• Est. completion date: December 2007

Study information

• Verified date: January 2003
• Source: National Institute of Cancerología
• Contact: Jose F Carrillo, M.D.
• Phone: +52 (55) 56280400
• Email: josecar[@]prodigy.net.mx
• Is FDA regulated: No
• Health authority: Mexico: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Consecutive patients with parotid gland masses

Study Design

Intervention Model: Single Group Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Parotid Gland Neoplasms
• Parotid Neoplasms

Intervention

Procedure:
• aspiration biopsy
fine needle aspiration biopsy of the parotid gland masses

Locations

Country	Name	City	State
Mexico	National Cancer Institute	Mexico	D.f:

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Cancerología

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnosis of malignancy		three years
Secondary	Specific histopathologic diagnosis		three years