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Trial record 2 of 190 for:    Oral Cancer | ( Map: Mexico )

Diagnostic Accuracy of Fine Needle Aspiration in Parotid Tumors

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ClinicalTrials.gov Identifier: NCT00534612
Recruitment Status : Unknown
Verified January 2003 by National Institute of Cancerología.
Recruitment status was:  Recruiting
First Posted : September 26, 2007
Last Update Posted : September 26, 2007
Sponsor:
Information provided by:
National Institute of Cancerología

Tracking Information
First Submitted Date  ICMJE September 21, 2007
First Posted Date  ICMJE September 26, 2007
Last Update Posted Date September 26, 2007
Study Start Date  ICMJE January 2003
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: September 24, 2007)
Diagnosis of malignancy [ Time Frame: three years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 24, 2007)
Specific histopathologic diagnosis [ Time Frame: three years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Diagnostic Accuracy of Fine Needle Aspiration in Parotid Tumors
Official Title  ICMJE Accuracy of Fine Needle Aspiration Biopsy in the Pre-Operative Diagnosis of Malignancy in Patients With Parotid Gland Masses
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.

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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: September 24, 2007)
150
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Consecutive patients with parotid gland masses
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Mexico
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00534612
Other Study ID Numbers  ICMJE 006/038/CCI
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE National Institute of Cancerología
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jose F Carrillo, M.D: National Cancer Institute, Mexico
PRS Account National Institute of Cancerología
Verification Date January 2003

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