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Diagnostic Accuracy of Fine Needle Aspiration in Parotid Tumors

Primary Purpose

Parotid Gland Neoplasms

Status

Unknown status

Phase

Early Phase 1

Locations

Mexico

Study Type

Interventional

Intervention

aspiration biopsy

About this trial

This is an interventional diagnostic trial for Parotid Gland Neoplasms focused on measuring Parotid gland neoplasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Consecutive patients with parotid gland masses

Sites / Locations

National Cancer InstituteRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

fine needle aspiration biopsy of the parotid gland mass

Outcomes

Primary Outcome Measures

Diagnosis of malignancy

Secondary Outcome Measures

Specific histopathologic diagnosis

Full Information

NCT ID

NCT00534612

First Posted

September 21, 2007

Last Updated

September 24, 2007

Sponsor

National Institute of Cancerología

1. Study Identification

Unique Protocol Identification Number

NCT00534612

Brief Title

Diagnostic Accuracy of Fine Needle Aspiration in Parotid Tumors

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2003

Overall Recruitment Status

Unknown status

Study Start Date

January 2003 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

December 2007 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

National Institute of Cancerología

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Parotid Gland Neoplasms

Keywords

Parotid gland neoplasms

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Early Phase 1

Interventional Study Model

Single Group Assignment

Masking

InvestigatorOutcomes Assessor

Allocation

N/A

Enrollment

150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

fine needle aspiration biopsy of the parotid gland mass

Intervention Type

Procedure

Intervention Name(s)

aspiration biopsy

Intervention Description

fine needle aspiration biopsy of the parotid gland masses

Primary Outcome Measure Information:

Title

Diagnosis of malignancy

Time Frame

three years

Secondary Outcome Measure Information:

Title

Specific histopathologic diagnosis

Time Frame

three years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Consecutive patients with parotid gland masses

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jose F Carrillo, M.D.

Phone

+52 (55) 56280400

Ext

284

josecar@prodigy.net.mx

First Name & Middle Initial & Last Name or Official Title & Degree

Luis F Oñate-Ocaña, M.D:

Phone

´52 (55) 56280400

Ext

120

lfonate@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jose F Carrillo, M.D:

Organizational Affiliation

National Cancer Institute, Mexico

Official's Role

Principal Investigator

Facility Information:

Facility Name

National Cancer Institute

City

Mexico

State/Province

D.f:

ZIP/Postal Code

14080

Country

Mexico

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jose F Carrillo, M.D.

12. IPD Sharing Statement

Learn more about this trial

Diagnostic Accuracy of Fine Needle Aspiration in Parotid Tumors

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