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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:
Information provided by:
National Institute of Cancerología
ClinicalTrials.gov Identifier:
NCT00534612
First received: September 21, 2007
Last updated: September 24, 2007
Last verified: January 2003
  Purpose
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.

Condition Intervention Phase
Parotid Gland Neoplasms
Procedure: aspiration biopsy
Phase 0

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by National Institute of Cancerología:

Primary Outcome Measures:
  • Diagnosis of malignancy [ Time Frame: three years ]

Secondary Outcome Measures:
  • Specific histopathologic diagnosis [ Time Frame: three years ]

Estimated Enrollment: 150
Study Start Date: January 2003
Estimated Study Completion Date: December 2007
Arms Assigned Interventions
Experimental: 1
fine needle aspiration biopsy of the parotid gland mass
Procedure: aspiration biopsy
fine needle aspiration biopsy of the parotid gland masses

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Consecutive patients with parotid gland masses
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00534612

Locations
Mexico
National Cancer Institute
Mexico, D.f:, Mexico, 14080
Sponsors and Collaborators
National Institute of Cancerología
Investigators
Principal Investigator: Jose F Carrillo, M.D: National Cancer Institute, Mexico
  More Information

ClinicalTrials.gov Identifier: NCT00534612     History of Changes
Other Study ID Numbers: 006/038/CCI 
Study First Received: September 21, 2007
Last Updated: September 24, 2007
Health Authority: Mexico: Ethics Committee

Keywords provided by National Institute of Cancerología:
Parotid gland neoplasms

Additional relevant MeSH terms:
Parotid Neoplasms
Salivary Gland Neoplasms
Mouth Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Mouth Diseases
Stomatognathic Diseases
Parotid Diseases
Salivary Gland Diseases

ClinicalTrials.gov processed this record on December 02, 2016