Diagnostic Accuracy of Fine Needle Aspiration in Parotid Tumors
The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2003 by National Institute of Cancerología.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
National Institute of Cancerología
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
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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 |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Consecutive patients with parotid gland masses
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00534612
Contacts
| Contact: Jose F Carrillo, M.D. | +52 (55) 56280400 ext 284 | josecar@prodigy.net.mx |
| Contact: Luis F Oñate-Ocaña, M.D: | ´52 (55) 56280400 ext 120 | lfonate@gmail.com |
Locations
| Mexico | |
| National Cancer Institute | Recruiting |
| Mexico, D.f:, Mexico, 14080 | |
| Principal Investigator: Jose F Carrillo, M.D. | |
Sponsors and Collaborators
National Institute of Cancerología
Investigators
| Principal Investigator: | Jose F Carrillo, M.D: | National Cancer Institute, Mexico |
More Information
No publications provided
| 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:
|
Neoplasms Parotid Neoplasms Salivary Gland Neoplasms Mouth Neoplasms Head and Neck Neoplasms |
Neoplasms by Site Mouth Diseases Stomatognathic Diseases Parotid Diseases Salivary Gland Diseases |
ClinicalTrials.gov processed this record on May 19, 2013