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


Phase 0
18 Years
N/A
Open (Enrolling)
Both
Parotid Gland Neoplasms

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Trial Information

Accuracy of Fine Needle Aspiration Biopsy in the Pre-Operative Diagnosis of Malignancy in Patients With 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.


Inclusion Criteria:



- Consecutive patients with parotid gland masses

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Diagnostic

Outcome Measure:

Diagnosis of malignancy

Outcome Time Frame:

three years

Principal Investigator

Jose F Carrillo, M.D:

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cancer Institute, Mexico

Authority:

Mexico: Ethics Committee

Study ID:

006/038/CCI

NCT ID:

NCT00534612

Start Date:

January 2003

Completion Date:

December 2007

Related Keywords:

  • Parotid Gland Neoplasms
  • Parotid gland neoplasms
  • Neoplasms
  • Parotid Neoplasms

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