NCT00551486

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
101

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2006

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2006

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

October 30, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 31, 2007

Completed
Last Updated

October 31, 2007

Status Verified

October 1, 2007

First QC Date

October 30, 2007

Last Update Submit

October 30, 2007

Conditions

Thyroid Neoplasms

Keywords

PyrosequencingBRAFV600E mutationThyroid incidentalomaUltrasound-guided fine-needle aspiration biopsy

Study Arms (1)

1

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

Procedure: ultrasound-guided fine needle aspiration biopsy

Interventions

ultrasound-guided fine needle aspiration biopsyPROCEDURE

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.

1

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

1. Patients with thyroid nodule larger than 1 cm, or nodule smaller than 1 cm that required further evaluation because of suspicious ultrasound findings 2. The average size of the nodules was 1.0 cm.

You may qualify if:

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

You may not qualify if:

  • Patients who refuse participation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chungnam National University Hospital

Daejeon, 301-721, South Korea

Location

Biospecimen

Retention: SAMPLES WITH DNA

Fine needle aspiration samples of thyroid nodule

MeSH Terms

Conditions

Thyroid Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsEndocrine System DiseasesThyroid Diseases

Study Officials

  • Minho Shong, M.D., Ph.D.

    Chungnam National University

    STUDY DIRECTOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 30, 2007

First Posted

October 31, 2007

Study Start

June 1, 2006

Study Completion

December 1, 2006

Last Updated

October 31, 2007

Record last verified: 2007-10

Locations

KR(1)