Diagnostic Accuracy of Fine Needle Aspiration in Parotid Tumors

National Institute of Cancerología

Status and phase: Unknown; Early Phase 1

Conditions: Parotid Gland Neoplasms

Treatments: Procedure: aspiration biopsy

Study type: Interventional

Funder types: Other

Identifiers

NCT00534612

006/038/CCI

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Consecutive patients with parotid gland masses

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: Double Blind

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150 participants in 1 patient group

1

Experimental group

Description:

fine needle aspiration biopsy of the parotid gland mass

Treatment:

Procedure: aspiration biopsy