Diagnostic Accuracy of Fine Needle Aspiration in Parotid Tumors

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

Status

UNKNOWN

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00534612

Enrollment

150

Registered

2007-09-26

Start date

2003-01-31

Completion date

2007-12-31

Last updated

2007-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parotid Gland Neoplasms

Keywords

Parotid gland neoplasms

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.

Interventions

PROCEDUREaspiration biopsy

fine needle aspiration biopsy of the parotid gland masses

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Consecutive patients with parotid gland masses

Design outcomes

Primary

Measure	Time frame
Diagnosis of malignancy	three years

Secondary

Measure	Time frame
Specific histopathologic diagnosis	three years

Countries

Mexico

Contacts

Primary ContactJose F Carrillo, M.D.

josecar@prodigy.net.mx+52 (55) 56280400

Backup ContactLuis F Oñate-Ocaña, M.D:

lfonate@gmail.com´52 (55) 56280400

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026