Pyrosequencing of the BRAFV600E Mutation

This study has been completed.

Sponsor:

Information provided by:

Chungnam National University

ClinicalTrials.gov Identifier:

NCT00551486

First received: October 30, 2007

Last updated: NA

Last verified: October 2007

History: No changes posted

Tracking Information

First Received Date ^ICMJE

October 30, 2007

Last Updated Date

October 30, 2007

Start Date ^ICMJE

June 2006

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Pyrosequencing of the BRAFV600E Mutation

Official Title ^ICMJE

Diagnostic Value of Pyrosequencing for the BRAFV600E Mutation in Ultrasound-Guided Fine-Needle Aspiration Biopsy Samples of Thyroid Incidentalomas

Brief Summary

To investigate the diagnostic efficiency of pyrosequencing for the mutant BRAF allele in ultrasound (US)-guided fine needle aspiration biopsies (FNAB) of thyroid incidentalomas.

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Retention: Samples With DNA

Description:

Fine needle aspiration samples of thyroid nodule

Sampling Method

Non-Probability Sample

Study Population

Patients with thyroid nodule larger than 1 cm, or nodule smaller than 1 cm that required further evaluation because of suspicious ultrasound findings
The average size of the nodules was 1.0 cm.

Condition ^ICMJE

Thyroid Neoplasms

Intervention ^ICMJE

Procedure: ultrasound-guided fine needle aspiration biopsy

Fine needle aspiration (FNA)with cytologic analysis has become a mainstay of thyroid nodule evaluation was used. Nonpalpable nodules were aspirated under ultrasound guidance to facilitate precise targeting of the nodule and to sample the part most likely to improve diagnostic yield.

Study Group/Cohort (s)

Patients with thyroid incidentaloma underwent ultrasound-guided fine needle aspiration biopsy

Intervention: Procedure: ultrasound-guided fine needle 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

Completed

Enrollment ^ICMJE

101

Completion Date

December 2006

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Patients with thyroid nodule larger than 1 cm, or nodule smaller than 1 cm that required further evaluation because of suspicious ultrasound findings

Exclusion Criteria:

Patients who refuse participation.

Gender

Both

Ages

20 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Korea, Republic of

Administrative Information

NCT Number ^ICMJE

NCT00551486

Other Study ID Numbers ^ICMJE

071027

Has Data Monitoring Committee

Yes

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Chungnam National University

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Minho Shong, M.D., Ph.D.

Chungnam National University

Information Provided By

Chungnam National University

Verification Date

October 2007

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

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