Diagnostic Accuracy of Fine Needle Aspiration in Parotid Tumors

NCT ID: NCT00534612

Last Updated: 2007-09-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-01-31

Study Completion Date

2007-12-31

Brief Summary

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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

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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.

Conditions

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Parotid Gland Neoplasms

Keywords

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Parotid gland neoplasms

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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1

fine needle aspiration biopsy of the parotid gland mass

Group Type EXPERIMENTAL

aspiration biopsy

Intervention Type PROCEDURE

fine needle aspiration biopsy of the parotid gland masses

Interventions

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aspiration biopsy

fine needle aspiration biopsy of the parotid gland masses

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Consecutive patients with parotid gland masses
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Cancerología

OTHER_GOV

Sponsor Role lead

Principal Investigators

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Jose F Carrillo, M.D:

Role: PRINCIPAL_INVESTIGATOR

Instituto Nacional de Cancerologia de Mexico

Locations

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National Cancer Institute

México, D.F:, Mexico

Site Status RECRUITING

Countries

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Mexico

Central Contacts

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Jose F Carrillo, M.D.

Role: CONTACT

Phone: +52 (55) 56280400

Email: [email protected]

Luis F Oñate-Ocaña, M.D:

Role: CONTACT

Phone: ´52 (55) 56280400

Email: [email protected]

Other Identifiers

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006/038/CCI

Identifier Type: -

Identifier Source: org_study_id