Thyroid NoduleTIRADSNCT04488640
Compliance of Thyroid Fine Needle Aspiration Biopsy and Trucut Biopsy Results With TIRADS Score and Surgical Pathology
An observational study of Thyroid Nodule, run by Bezmialem Vakif University.
Trial summary
The investigators retrospectively reviewed the medical records of 760 patients with thyroid nodule biopsy and 88 patients who had thyroid surgery. The investigators evaluated patients' thyroid ultrasonography reports and determined Thyroid Imaging Reporting and Data System scores (TIRADS score: 1-Benign, 2- very low… Read more about this study
- Who is it for?
- Ages 24 to 85 years
- Conditions the study is for
- Thyroid Nodule
- What is being tested?
- Thyroid biopsy with ultrasound
- Type of treatment
- Surgery or procedure
- How many people
- 4 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2017to 1 May 2020
- 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 24 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Thyroid biopsy data of 691 women and 69 men aged between 24-85 years were evaluated.
Who may be able to join
- Having a thyroid nodule
- Being both a thyroid needle and a core biopsy
Who cannot join
- Child patients
- Pregnant patients
- Patients without a thyroid needle biopsy
About this study
Official title: Compliance of Thyroid Fine Needle Aspiration Biopsy and Trucut Biopsy Results With Thyroid Imaging Reporting and Data System Score and Surgical Pathology
The investigators retrospectively reviewed the medical records of 760 patients with thyroid nodule biopsy and 88 patients who had thyroid surgery. The investigators evaluated patients' thyroid ultrasonography reports and determined Thyroid Imaging Reporting and Data System scores (TIRADS score: 1-Benign, 2- very low malignant) risk, 3-low risk, 4-medium risk, 5 -malignant high risk). The investigators evaluated patients 'existing thyroid fine needle aspiration biopsy (FNAB) reports and recorded the patients' cytology results (benign, malignant).
Documents of 88 patients who were included in the study and who underwent thyroidectomy were reviewed.Pathology reports of these patients were evaluated and surgical pathology was determined as benign in 58 patients and malignant in 30 patients.
Then, a statistical study was performed between the cor needle biopsy (CNB) results of these participants and the surgical pathology and TI-RADS scores.
- Conditions
- Thyroid Nodule
- Being tested
- Thyroid biopsy with ultrasound
- Keywords
- TI-RADS score, Thyroid fine needle aspiration biopsy, Thyroid core needle biopsy, Surgical pathology
- Medical subject headings
- Thyroid Nodule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thyroid biopsy with ultrasoundProcedure or surgery
Also called Total thyroidectomy
Patients with thyroid nodules who underwent ultrasound-guided core needle biopsy with a 20 gauge core needle biopsy apparatus were included in the study.
| Study group | Role | What they receive |
|---|---|---|
| Thyroid fine needle aspiration biopsy group | A group of 760 people who had a thyroid nodule and who had a thyroid fine needle aspiration biopsy for diagnosis. Receives: Procedure: Thyroid biopsy with ultrasound | |
| Thyroid core needle aspiration biopsy group | A patient group with 760 people who had a thyroid nodule and who had a thyroid fine needle aspiration biopsy for diagnosis and who underwent a core needle biopsy again. A total thyroidectomy was performed in 88 of these patients. Surgical pathology results, core needle results and TIRADS scores were compared. Receives: Procedure: Thyroid biopsy with ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the distribution of patients according to thyroid biopsy results.
Thyroid biopsy results (benign, malignant) will be compared with % of patients with these results. It will be analyzed statistically.
Measured: 4-year results were included.
Examination of TIRADS score distribution according to thyroid biopsy results.
Thyroid biopsy results (benign, malignant) will be compared with the percentage of patients who fit the TIRADS score distribution (1-5). It will be analyzed statistically.
Measured: 4-year results were included.
Evaluation of the compliance of TI-RADS scores with surgical pathology reports.
Surgical pathology results (benign, malignant) and TI-RADS scores (1 to 5) will be compared with% of patients matching the distribution (1-5). It will be analyzed statistically.
Measured: 4-year results were included.
Evaluation of the distribution of thyroid biopsy results and surgical pathology results.
The % of patients who match the distribution of thyroid biopsy results (benign, malignant) and surgical pathology results (benign, malignant) will be compared. It will be analyzed statistically.
Measured: 4-year results were included.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2020
- Study start1 Jan 2017
- Primary completion1 Jan 2020
- Study completion1 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Thyroid NoduleStudies of the same condition, open and under way.
- More trials run by Bezmialem Vakif UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sabahattin Destek, Bezmialem Vakif University
- Investigators
- Beyza Benturk, Dr, Study chair, Bezmialem Vakif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04488640
- Sponsor's protocol ID
- 8131643
- Acronym
- TIRADS
- Status last verified
- Jul 2020
- First submitted
- 15 Jul 2020
- Last updated
- 28 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We retrospectively analyzed the medical records of 760 patients with thyroid nodule biopsy and 88 patients who had thyroid surgery. We retrospectively analyzed the medical records of 760 patients who had undergone thyroid fine needle aspiration biopsy and core needle biopsy (CNB) and 88 patients who had thyroid surgery. After the study, core needle biopsy results were statistically compatible with Thyroid Imaging Reporting and Data System (TI-RADS) scores and surgical pathology results in patients. As a result, CNB is a reliable diagnostic method.
Publications
Singh Ospina N, Brito JP, Maraka S, Espinosa de Ycaza AE, Rodriguez-Gutierrez R, Gionfriddo MR, Castaneda-Guarderas A, Benkhadra K, Al Nofal A, Erwin P, Morris JC, Castro MR, Montori VM. Diagnostic accuracy of ultrasound-guided fine needle aspiration biopsy for thyroid malignancy: systematic review and meta-analysis. Endocrine. 2016 Sep;53(3):651-61. doi: 10.1007/s12020-016-0921-x. Epub 2016 Apr 12.
PubMed 27071659Singaporewalla RM, Hwee J, Lang TU, Desai V. Clinico-pathological Correlation of Thyroid Nodule Ultrasound and Cytology Using the TIRADS and Bethesda Classifications. World J Surg. 2017 Jul;41(7):1807-1811. doi: 10.1007/s00268-017-3919-5.
PubMed 28251273Lew JI, Snyder RA, Sanchez YM, Solorzano CC. Fine needle aspiration of the thyroid: correlation with final histopathology in a surgical series of 797 patients. J Am Coll Surg. 2011 Jul;213(1):188-94; discussion 194-5. doi: 10.1016/j.jamcollsurg.2011.04.029. Epub 2011 May 20.
PubMed 21601489Kim SY, Lee HS, Moon J, Kim EK, Moon HJ, Yoon JH, Kwak JY. Fine-needle aspiration versus core needle biopsy for diagnosis of thyroid malignancy and neoplasm: a matched cohort study. Eur Radiol. 2017 Feb;27(2):801-811. doi: 10.1007/s00330-016-4424-1. Epub 2016 Jun 3.
PubMed 27260342Hahn SY, Shin JH, Oh YL, Park KW, Lim Y. Comparison Between Fine Needle Aspiration and Core Needle Biopsy for the Diagnosis of Thyroid Nodules: Effective Indications According to US Findings. Sci Rep. 2020 Mar 18;10(1):4969. doi: 10.1038/s41598-020-60872-z.
PubMed 32188891
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compliance of Thyroid Fine Needle Aspiration Biopsy and Trucut Biopsy Results With Thyroid Imaging Reporting and Data System Score and Surgical Pathology
- ClinicalTrials.gov ID
- NCT04488640
- Acronym / sponsor ID
- TIRADS / 8131643
- Conditions
- Thyroid Nodule
- Keywords
- TI-RADS score, Thyroid fine needle aspiration biopsy, Thyroid core needle biopsy, Surgical pathology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 1 May 2020 (actual)
- First posted
- 28 Jul 2020 (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.
The investigators retrospectively reviewed the medical records of 760 patients with thyroid nodule biopsy and 88 patients who had thyroid surgery. The investigators evaluated patients' thyroid ultrasonography reports and determined Thyroid Imaging Reporting and Data System scores (TIRADS score: 1-Benign, 2- very low malignant) risk, 3-low risk, 4-medium risk, 5 -malignant high risk). The investigators evaluated patients 'existing thyroid fine needle aspiration biopsy (FNAB) reports and recorded the patients' cytology results (benign, malignant).
Documents of 88 patients who were included in the study and who underwent thyroidectomy were reviewed.Pathology reports of these patients were evaluated and surgical pathology was determined as benign in 58 patients and malignant in 30 patients.
Then, a statistical study was performed between the cor needle biopsy (CNB) results of these participants and the surgical pathology and TI-RADS scores.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thyroid fine needle aspiration biopsy group | – | Procedure: Thyroid biopsy with ultrasoundA group of 760 people who had a thyroid nodule and who had a thyroid fine needle aspiration biopsy for diagnosis. |
| Thyroid core needle aspiration biopsy group | – | Procedure: Thyroid biopsy with ultrasoundA patient group with 760 people who had a thyroid nodule and who had a thyroid fine needle aspiration biopsy for diagnosis and who underwent a core needle biopsy again. A total thyroidectomy was performed in 88 of these patients. Surgical pathology results, core needle results and TIRADS scores were compared. |
Who may qualify
- Ages
- 24 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Thyroid biopsy data of 691 women and 69 men aged between 24-85 years were evaluated.
Key inclusion criteria (2 listed)
- Having a thyroid nodule
- Being both a thyroid needle and a core biopsy
Key exclusion criteria (3 listed)
- Child patients
- Pregnant patients
- Patients without a thyroid needle biopsy
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 |
|---|---|---|
| Thyroid biopsy with ultrasoundAlso: Total thyroidectomyPatients with thyroid nodules who underwent ultrasound-guided core needle biopsy with a 20 gauge core needle biopsy apparatus were included in the study. | Procedure or surgery | Thyroid core needle aspiration biopsy group, Thyroid fine needle aspiration biopsy group |
Primary outcome
Evaluation of the distribution of patients according to thyroid biopsy results.
Time frame: 4-year results were included.
Thyroid biopsy results (benign, malignant) will be compared with % of patients with these results. It will be analyzed statistically.
Examination of TIRADS score distribution according to thyroid biopsy results.
Time frame: 4-year results were included.
Thyroid biopsy results (benign, malignant) will be compared with the percentage of patients who fit the TIRADS score distribution (1-5). It will be analyzed statistically.
Evaluation of the compliance of TI-RADS scores with surgical pathology reports.
Time frame: 4-year results were included.
Surgical pathology results (benign, malignant) and TI-RADS scores (1 to 5) will be compared with% of patients matching the distribution (1-5). It will be analyzed statistically.
Evaluation of the distribution of thyroid biopsy results and surgical pathology results.
Time frame: 4-year results were included.
The % of patients who match the distribution of thyroid biopsy results (benign, malignant) and surgical pathology results (benign, malignant) will be compared. It will be analyzed statistically.
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 28 Jul 2020.
- Results publication: PubMed 27071659Singh Ospina N, Brito JP, Maraka S, Espinosa de Ycaza AE, Rodriguez-Gutierrez R, Gionfriddo MR, Castaneda-Guarderas A, Benkhadra K, Al Nofal A, Erwin P, Morris JC, Castro MR, Montori VM. Diagnostic accuracy of ultrasound-guided fine needle aspiration biopsy for thyroid malignancy: systematic review and meta-analysis. Endocrine. 2016 Sep;53(3):651-61. doi: 10.1007/s12020-016-0921-x. Epub 2016 Apr 12.
- Results publication: PubMed 28251273Singaporewalla RM, Hwee J, Lang TU, Desai V. Clinico-pathological Correlation of Thyroid Nodule Ultrasound and Cytology Using the TIRADS and Bethesda Classifications. World J Surg. 2017 Jul;41(7):1807-1811. doi: 10.1007/s00268-017-3919-5.
- Results publication: PubMed 21601489Lew JI, Snyder RA, Sanchez YM, Solorzano CC. Fine needle aspiration of the thyroid: correlation with final histopathology in a surgical series of 797 patients. J Am Coll Surg. 2011 Jul;213(1):188-94; discussion 194-5. doi: 10.1016/j.jamcollsurg.2011.04.029. Epub 2011 May 20.
- Results publication: PubMed 27260342Kim SY, Lee HS, Moon J, Kim EK, Moon HJ, Yoon JH, Kwak JY. Fine-needle aspiration versus core needle biopsy for diagnosis of thyroid malignancy and neoplasm: a matched cohort study. Eur Radiol. 2017 Feb;27(2):801-811. doi: 10.1007/s00330-016-4424-1. Epub 2016 Jun 3.
- Results publication: PubMed 32188891Hahn SY, Shin JH, Oh YL, Park KW, Lim Y. Comparison Between Fine Needle Aspiration and Core Needle Biopsy for the Diagnosis of Thyroid Nodules: Effective Indications According to US Findings. Sci Rep. 2020 Mar 18;10(1):4969. doi: 10.1038/s41598-020-60872-z.
- Individual participant dataSharing planned: Undecided. We retrospectively analyzed the medical records of 760 patients with thyroid nodule biopsy and 88 patients who had thyroid surgery. We retrospectively analyzed the medical records of 760 patients who had undergone thyroid fine needle aspiration biopsy and core needle biopsy (CNB) and 88 patients who had thyroid surgery. After the study, core needle biopsy results were statistically compatible with Thyroid Imaging Reporting and Data System (TI-RADS) scores and surgical pathology results in patients. As a result, CNB is a reliable diagnostic method.
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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.
Beyza Benturk, Dr study chair
Bezmialem Vakif University
Questions about this trial
What is this clinical trial studying?
An observational study of Thyroid Nodule, run by Bezmialem Vakif University.
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 3 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 28 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
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.
What does the primary outcome measure?
Evaluation of the distribution of patients according to thyroid biopsy results. (time frame: 4-year results were included.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04488640, which also lists 5 linked publications.
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 28 Jul 2020.