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Diagnostic Accuracy of Fine Needle Aspiration in Parotid Tumors

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2003 by National Institute of Cancerología.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00534612
First Posted: September 26, 2007
Last Update Posted: September 26, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Institute of Cancerología
September 21, 2007
September 26, 2007
September 26, 2007
January 2003
Not Provided
Diagnosis of malignancy [ Time Frame: three years ]
Same as current
No Changes Posted
Specific histopathologic diagnosis [ Time Frame: three years ]
Same as current
Not Provided
Not Provided
 
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
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.

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.

Interventional
Early Phase 1
Intervention Model: Single Group Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Parotid Gland Neoplasms
Procedure: aspiration biopsy
fine needle aspiration biopsy of the parotid gland masses
Experimental: 1
fine needle aspiration biopsy of the parotid gland mass
Intervention: Procedure: aspiration biopsy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
150
December 2007
Not Provided

Inclusion Criteria:

  • Consecutive patients with parotid gland masses
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Mexico
 
 
NCT00534612
006/038/CCI
No
Not Provided
Not Provided
Not Provided
National Institute of Cancerología
Not Provided
Principal Investigator: Jose F Carrillo, M.D: National Cancer Institute, Mexico
National Institute of Cancerología
January 2003

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP