Diagnostic Accuracy of Fine Needle Aspiration in Parotid Tumors
Recruitment status was Recruiting
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.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
|Official Title:||Accuracy of Fine Needle Aspiration Biopsy in the Pre-Operative Diagnosis of Malignancy in Patients With Parotid Gland Masses|
- Diagnosis of malignancy [ Time Frame: three years ]
- Specific histopathologic diagnosis [ Time Frame: three years ]
|Study Start Date:||January 2003|
|Estimated Study Completion Date:||December 2007|
fine needle aspiration biopsy of the parotid gland mass
Procedure: aspiration biopsy
fine needle aspiration biopsy of the parotid gland masses
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00534612
|Contact: Jose F Carrillo, M.D.||+52 (55) 56280400 ext firstname.lastname@example.org|
|Contact: Luis F Oñate-Ocaña, M.D:||´52 (55) 56280400 ext email@example.com|
|National Cancer Institute||Recruiting|
|Mexico, D.f:, Mexico, 14080|
|Principal Investigator: Jose F Carrillo, M.D.|
|Principal Investigator:||Jose F Carrillo, M.D:||National Cancer Institute, Mexico|