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Status unknownNCT00534612Updated Sep 26, 2007

Diagnostic Accuracy of Fine Needle Aspiration in Parotid Tumors

An Early Phase 1 interventional study of aspiration biopsy in Parotid Gland Neoplasms, sponsored by National Institute of Cancerología. Status unknown at 1 site in Mexico. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2007-09-26.

Sponsored by National Institute of Cancerología · Early Phase 1, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Jan 2003), so the status shown — last known as Recruiting — may be out of date.
Phase
Early Phase 1
Study type
Interventional
Enrollment
150
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Parotid Gland Neoplasms

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Keywords

  • Parotid gland neoplasms
03

In context

Parotid Neoplasms

27 studies on the registry are indexed under Parotid Neoplasms; 7 are open to participants now.

This study's planned enrollment of 150 is above the median of 55 across 20 interventional studies indexed under Parotid Neoplasms.

Browse Parotid Neoplasms studies →

Lead sponsor

National Institute of Cancerología is the lead sponsor of 38 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria:

  • Consecutive patients with parotid gland masses
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Study design

Phase
Early Phase 1
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
Double (Investigator, Outcomes assessor)
Enrollment
150 participants (estimated)

Study arms

  • Experimental
    1

    fine needle aspiration biopsy of the parotid gland mass

    Procedure: aspiration biopsy

Interventions

  • Procedureaspiration biopsy

    fine needle aspiration biopsy of the parotid gland masses

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What researchers measure

Primary outcomes

  1. Diagnosis of malignancy

    Time frame: three years

Secondary outcomes

  1. Specific histopathologic diagnosis

    Time frame: three years

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Study locations

1 of 1 sites recruiting
  • National Cancer Institute
    Mexico, D.f: 14080, Mexico
    • Jose F Carrillo, M.D. · Principal investigator
    Recruiting
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 26, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00534612
Lead sponsor
National Institute of Cancerología
First posted
Sep 26, 2007
Start date
Jan 2003
Completion
Dec 2007 (estimated)
Last update
Sep 26, 2007

Study contacts

Jose F Carrillo, M.D.
Contact
josecar@prodigy.net.mx
+52 (55) 56280400 ext. 284
Luis F Oñate-Ocaña, M.D:
Contact
lfonate@gmail.com
´52 (55) 56280400 ext. 120
Jose F Carrillo, M.D:
principal investigator · National Cancer Institute, Mexico

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2003. You cannot join it, but the record below documents what was studied.

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