Thyroid NeoplasmsNCT00551486
Pyrosequencing of the BRAFV600E Mutation
An observational study of Thyroid Neoplasms, run by Chungnam National University at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Thyroid Neoplasms
- What is being tested?
- ultrasound-guided fine needle aspiration biopsy
- Type of treatment
- Surgery or procedure
- How many people
- 101 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2006to Dec 2006
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Patients with thyroid nodule larger than 1 cm, or nodule smaller than 1 cm that required further evaluation because of suspicious ultrasound findings
Who cannot join
- Patients who refuse participation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diagnostic Value of Pyrosequencing for the BRAFV600E Mutation in Ultrasound-Guided Fine-Needle Aspiration Biopsy Samples of Thyroid Incidentalomas
To investigate the diagnostic efficiency of pyrosequencing for the mutant BRAF allele in ultrasound (US)-guided fine needle aspiration biopsies (FNAB) of thyroid incidentalomas.
- Conditions
- Thyroid Neoplasms
- Being tested
- ultrasound-guided fine needle aspiration biopsy
- Keywords
- Pyrosequencing, BRAFV600E mutation, Thyroid incidentaloma, Ultrasound-guided fine-needle aspiration biopsy
- Medical subject headings
- Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound-guided fine needle aspiration biopsyProcedure or surgery
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 | Role | What they receive |
|---|---|---|
| 1 | Patients with thyroid incidentaloma underwent ultrasound-guided fine needle aspiration biopsy Receives: Procedure: ultrasound-guided fine needle aspiration biopsy |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2007 (estimated)
- Study startJun 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chungnam National University
- Sponsor type
- University, hospital or other
- Investigators
- Minho Shong, M.D., Ph.D., Study director, Chungnam National University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00551486
- Sponsor's protocol ID
- 071027
- Status last verified
- Oct 2007
- First submitted
- 30 Oct 2007
- Last updated
- 31 Oct 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Value of Pyrosequencing for the BRAFV600E Mutation in Ultrasound-Guided Fine-Needle Aspiration Biopsy Samples of Thyroid Incidentalomas
- ClinicalTrials.gov ID
- NCT00551486
- Acronym / sponsor ID
- 071027
- Conditions
- Thyroid Neoplasms
- Keywords
- Pyrosequencing, BRAFV600E mutation, Thyroid incidentaloma, Ultrasound-guided fine-needle aspiration biopsy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Chungnam National UniversityUniversity, hospital or other
- Study start
- Jun 2006
- Study completion
- Dec 2006 (actual)
- First posted
- 31 Oct 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate the diagnostic efficiency of pyrosequencing for the mutant BRAF allele in ultrasound (US)-guided fine needle aspiration biopsies (FNAB) of thyroid incidentalomas.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Procedure: ultrasound-guided fine needle aspiration biopsyPatients with thyroid incidentaloma underwent ultrasound-guided fine needle aspiration biopsy |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Patients with thyroid nodule larger than 1 cm, or nodule smaller than 1 cm that required further evaluation because of suspicious ultrasound findings
Key exclusion criteria (1 listed)
- Patients who refuse participation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ultrasound-guided fine needle aspiration biopsyFine 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. | Procedure or surgery | 1 |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Minho Shong, M.D., Ph.D. study director
Chungnam National University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thyroid Neoplasms, run by Chungnam National University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Oct 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2007.