Thyroid NoduleNCT03517267
Thyroid Imaging Reporting and Data System (TIRADS ) Versus Thyroid Association (ATA) Guidelines
An observational study of Thyroid Nodule, run by Rambam Health Care Campus at 1 site in Israel.
Trial summary
Thyroid nodules are a very common clinical problem with prevalence of up to 68% in adults on high-resolution ultrasound .Ultrasound used in order to differentiate between benign and malignant lesion in the thyroid has shown sensitivity of 93.8% and specificity of 66% and US guided ( Fine needle aspiration ) FNA is… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroid Nodule
- What is being tested?
- ultrasound and FNA
- How many people
- 1,000 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Jun 2018to Jun 2019
- How long will I take part?
- 1 Year
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients referred for thyroid nodule FNA
Who may be able to join
- All patients referred for thyroid nodule FNA from outpatient and in patient clinics
- Patients older that 18
Who cannot join
- # Patients younger that 18
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Rambam Medical Center
Haifa, Israek
NIRA BECK-RAZI, md, 97247772664, n_beck_razi@rambam.health.gov.il
About this study
Official title: Validation of the New Thyroid Imaging Reporting and Data System (TIRADS) From 2017 Risk Assessment of Thyroid Nodules in Comparison to the American Thyroid Association (ATA) Guidelines From 2015
Thyroid nodules are a very common clinical problem with prevalence of up to 68% in adults on high-resolution ultrasound .Ultrasound used in order to differentiate between benign and malignant lesion in the thyroid has shown sensitivity of 93.8% and specificity of 66% and US guided ( Fine needle aspiration ) FNA is known to be the test of choice in order to determine the nodules nature . Four to 6.5 % of all nodules are malignant .There are several guidelines that were suggested to help predict the risk stratification of thyroid nodules by ultrasound .
The American Thyroid Association (ATA) is widely used as evaluation, clinical and ultrasound criteria for fine-needle aspiration biopsy and management of thyroid nodules. The recent ACR TIRADS is a reporting system for thyroid nodules on ultrasound proposed by the American College of Radiology (ACR) published april 2017 that uses a slightly different scoring system for recommendation for FNA of thyroid.
The aim of this study is to validate TIRADS ACR 2017 risk stratification in the patient population in comparison to ATA risk stratification
Read the detailed description
Thyroid nodules are a very common clinical problem with prevalence of up to 68% in adults on high-resolution ultrasound .Ultrasound used in order to differentiate between benign and malignant lesion in the thyroid has shown sensitivity of 93.8% and specificity of 66% and US guided ( Fine needle aspiration ) FNA is known to be the test of choice with sensitivity and specificity were 89.5% and 98%, respectively in order to determine the nodules nature, . Four to 6.5 % of all nodules are malignant .There are several guidelines that were suggested to help predict the risk stratification of thyroid nodules by ultrasound .
The American Thyroid Association (ATA) guidelines which characterized the nodule by its size, echogenicity, shape, presence or absence of calcification and evidence of Extrathyroidal extension (ETE) is widely use as evaluation, clinical and ultrasound criteria for fine-needle aspiration biopsy and management of thyroid nodules. These nodule characteristics classify the risk for malignancy into five categories which include benign pattern, very low suspicion pattern, low suspicion pattern, intermediate suspicious pattern and high suspicion pattern .
The recent ACR TIRADS is a reporting system for thyroid nodules on ultrasound proposed by the American College of Radiology (ACR) published april 2017 that uses a slightly different scoring system for recommendation for FNA of thyroid nodules .The ultrasound features set by TIRADS include composition, echogenicity, shape, margins and echogenic foci. The scoring range according suspicion of malignancy.
The aim of this study is to validate TIRADS ACR 2017 risk stratification in the patient population in comparison to ATA risk stratification.
Methods
The study will be prospective Informed consent will be signed before the FNA All patients referred for thyroid nodule FNA from outpatient and in patient clinics over 18 will be included .
The nodule to undergo FNA will be chosen according to TIRADS ACR criteria and the ATA risk criteria ( if there is a disagreement between the methods whether to perform FNA the FNA will be performed ) If both methods do not recommend FNA , but the referring doctor has requested the procedure or the patient is unable to stay on follow up , the FNA will be performed .
Data will be collected according the table Cytological results using Bethesda scoring and surgery results, when applicable will be collected .
- Conditions
- Thyroid Nodule
- Being tested
- ultrasound and FNA
- Medical subject headings
- Thyroid Nodule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound and FNADiagnostic test
The nodule to undergo FNA will be chosen according to TIRADS ACR criteria and the ATA risk criteria ( if there is a disagreement between the methods whether to perform FNA the FNA will be performed ) If both methods do not recommend FNA , but the referring doctor has requested the procedure or the patient is unable to stay on follow up , the FNA will be performed .
What is being measured
The primary outcome is the main question the study is designed to answer.
Validation of Risk stratifications
All nodules that will be aspirated , will be categorized according to the two risk stratification methods:
Thyroid Imaging Reporting and Data System (TIRADS) and the American Thyroid Association (ATA) guidelines. The cytology results will be documented in the form of Bethesda scoring The risk stratification results will be compared to the Cytology results that will be considered the gold standard for malignancy .
Accuracy of each method will be calculated .
Measured: The outcome measures will be assessed within 1 year from the initiation of recruitment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2018
- Study start1 Jun 2018
- Primary completionJun 2019 (estimated)
- Study completionJun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid NoduleStudies 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
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, razi-Beck Nira MD, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03517267
- Sponsor's protocol ID
- : RambamMC
- Status last verified
- Aug 2018
- First submitted
- 28 Mar 2018
- Last updated
- 31 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the New Thyroid Imaging Reporting and Data System (TIRADS) From 2017 Risk Assessment of Thyroid Nodules in Comparison to the American Thyroid Association (ATA) Guidelines From 2015
- ClinicalTrials.gov ID
- NCT03517267
- Acronym / sponsor ID
- : RambamMC
- Conditions
- Thyroid Nodule
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- Jun 2019 (estimated)
- Study completion
- Jun 2019 (estimated)
- First posted
- 7 May 2018 (actual)
- 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.
Thyroid nodules are a very common clinical problem with prevalence of up to 68% in adults on high-resolution ultrasound .Ultrasound used in order to differentiate between benign and malignant lesion in the thyroid has shown sensitivity of 93.8% and specificity of 66% and US guided ( Fine needle aspiration ) FNA is known to be the test of choice in order to determine the nodules nature . Four to 6.5 % of all nodules are malignant .There are several guidelines that were suggested to help predict the risk stratification of thyroid nodules by ultrasound .
The American Thyroid Association (ATA) is widely used as evaluation, clinical and ultrasound criteria for fine-needle aspiration biopsy and management of thyroid nodules. The recent ACR TIRADS is a reporting system for thyroid nodules on ultrasound proposed by the American College of Radiology (ACR) published april 2017 that uses a slightly different scoring system for recommendation for FNA of thyroid.
The aim of this study is to validate TIRADS ACR 2017 risk stratification in the patient population in comparison to ATA risk stratification
Detailed description
Thyroid nodules are a very common clinical problem with prevalence of up to 68% in adults on high-resolution ultrasound .Ultrasound used in order to differentiate between benign and malignant lesion in the thyroid has shown sensitivity of 93.8% and specificity of 66% and US guided ( Fine needle aspiration ) FNA is known to be the test of choice with sensitivity and specificity were 89.5% and 98%, respectively in order to determine the nodules nature, . Four to 6.5 % of all nodules are malignant .There are several guidelines that were suggested to help predict the risk stratification of thyroid nodules by ultrasound .
The American Thyroid Association (ATA) guidelines which characterized the nodule by its size, echogenicity, shape, presence or absence of calcification and evidence of Extrathyroidal extension (ETE) is widely use as evaluation, clinical and ultrasound criteria for fine-needle aspiration biopsy and management of thyroid nodules. These nodule characteristics classify the risk for malignancy into five categories which include benign pattern, very low suspicion pattern, low suspicion pattern, intermediate suspicious pattern and high suspicion pattern .
The recent ACR TIRADS is a reporting system for thyroid nodules on ultrasound proposed by the American College of Radiology (ACR) published april 2017 that uses a slightly different scoring system for recommendation for FNA of thyroid nodules .The ultrasound features set by TIRADS include composition, echogenicity, shape, margins and echogenic foci. The scoring range according suspicion of malignancy.
The aim of this study is to validate TIRADS ACR 2017 risk stratification in the patient population in comparison to ATA risk stratification.
Methods
The study will be prospective Informed consent will be signed before the FNA All patients referred for thyroid nodule FNA from outpatient and in patient clinics over 18 will be included .
The nodule to undergo FNA will be chosen according to TIRADS ACR criteria and the ATA risk criteria ( if there is a disagreement between the methods whether to perform FNA the FNA will be performed ) If both methods do not recommend FNA , but the referring doctor has requested the procedure or the patient is unable to stay on follow up , the FNA will be performed .
Data will be collected according the table Cytological results using Bethesda scoring and surgery results, when applicable will be collected .
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients referred for thyroid nodule FNA
Key inclusion criteria (2 listed)
- All patients referred for thyroid nodule FNA from outpatient and in patient clinics
- Patients older that 18
Key exclusion criteria (1 listed)
- # Patients younger that 18
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 and FNAThe nodule to undergo FNA will be chosen according to TIRADS ACR criteria and the ATA risk criteria ( if there is a disagreement between the methods whether to perform FNA the FNA will be performed ) If both methods do not recommend FNA , but the referring doctor has requested the procedure or the patient is unable to stay on follow up , the FNA will be performed . | Diagnostic test | – |
Primary outcome
Validation of Risk stratifications
Time frame: The outcome measures will be assessed within 1 year from the initiation of recruitment.
All nodules that will be aspirated , will be categorized according to the two risk stratification methods: Thyroid Imaging Reporting and Data System (TIRADS) and the American Thyroid Association (ATA) guidelines. The cytology results will be documented in the form of Bethesda scoring The risk stratification results will be compared to the Cytology results that will be considered the gold standard for malignancy . Accuracy of each method will be calculated .
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2018.
- Individual participant dataSharing planned: No
Related trials for Thyroid Nodule
RecruitingObservational study
Studies on Tumors of the Thyroid
Hurthle Cell Thyroid Cancer, Tall Cell Variant Thyroid Cancer
RecruitingObservational study
International PPB/DICER1 Registry
Pleuropulmonary Blastoma, Sertoli-Leydig Cell Tumor
Recruiting
Evaluation of DNA Methylation Signatures for the Diagnosis and Management of Thyroid Nodules
Thyroid Gland Carcinoma
Active, not recruiting
Thyroid Nodule Gene Sequencing in a Danish Population
Thyroid Nodule (Diagnosis), Thyroid Cancer
RecruitingObservational study
Renovated Prediction Model for Difficult Transoral and Submental Endoscopic Thyroidectomy
Thyroid Cancer, Thyroid Diseases
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.
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 Nodule, run by Rambam Health Care Campus at 1 site in Israel.
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 2 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: status not confirmed, as of the sponsor's last update on 31 Aug 2018. 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact NIRA BECK-RAZI, MD (97247772664, n_beck_razi@rambam.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validation of Risk stratifications (time frame: The outcome measures will be assessed within 1 year from the initiation of recruitment.). It is what the study was designed to measure, not a finding.
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 Aug 2018.