Diagnostic Accuracy of Fine Needle Aspiration in Parotid... | NCT00534612

Studies
Diagnostic Accuracy of Fine Needle Aspiration in Parotid Tumors

NCT00534612

Sponsor

National Institute of Cancerología

Status

Unknown status

Last Update Posted

Sep 26, 2007Estimated

Enrollment

150Estimated

Phase

Early Phase 1

Conditions

Parotid Gland Neoplasms

Interventions

aspiration biopsy

Countries

Mexico

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2003

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2003

Primary Completion Date

Not provided

Completion Date

Dec 2007Estimated

First Submitted Date

Sep 21, 2007

First Submission Date that Met QC Criteria

Sep 24, 2007

First Posted Date

Sep 26, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 24, 2007

Last Update Posted Date

Sep 26, 2007Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

150Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	fine needle aspiration biopsy of the parotid gland mass	Procedure: aspiration biopsy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
aspiration biopsy	Procedure	fine needle aspiration biopsy of the parotid gland masses	1

Measure	Description	Time Frame
Diagnosis of malignancy		three years

Measure	Description	Time Frame
Specific histopathologic diagnosis		three years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Consecutive patients with parotid gland masses

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jose F Carrillo, M.D.	Contact	+52 (55) 56280400	284	josecar@prodigy.net.mx
Luis F Oñate-Ocaña, M.D:	Contact	´52 (55) 56280400	120	lfonate@gmail.com

Overall Officials

Name	Affiliation	Role
Jose F Carrillo, M.D:	Instituto Nacional de Cancerologia de Mexico	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Cancer Institute	Recruiting	México	D.F:	14080	Mexico

Intervention Browse Module

MeSH Terms

ID	Term
D001707	Biopsy, Needle

Ancestor Terms

ID	Term
D001706	Biopsy
D003581	Cytodiagnosis
D003584	Cytological Techniques
D019411	Clinical Laboratory Techniques

Browse Leaves

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Browse Branches

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