Thyroid NoduleTIRADSNCT06391021
Comparison Between Combined Scoring of Bethesda Cytology and TIRADS Ultrasound With Histopathology in Thyroid Nodule
An observational study of Thyroid Nodule, run by Tribhuvan University, Nepal at 1 site in Nepal.
Trial summary
A thyroid nodule is a discrete lesion within the thyroid gland that is radiologically distinct from the surrounding thyroid parenchyma. Most thyroid nodules are benign, with only 10% to 15% harboring cancer. Read more about this study
- Who is it for?
- Ages 20 to 66 years
- Conditions the study is for
- Thyroid Nodule
- How many people
- 42 participants
- Where
- 1 siteNepal
- Study dates
- 20 Jun 2022to 15 Feb 2023
- 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 to 66 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All the participants with thyroid nodules who met the inclusion criteria within the study period were enrolled in the study . Total 42 participants were included in the study.
Who may be able to join
- 1.Patients presenting to Ear Nose and Throat, Head and Neck Surgery Department with thyroid nodules undergoing hemithyroidectomy or total thyroidectomy within the study period
Who cannot join
- 1.Patients refusing to give consent for the study. 2.Patients with already known case of thyroid malignancies proven by histopathological reports.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between Combined Scoring of Bethesda Cytology and TIRADS Ultrasound With Post- Operative Histopathology in Thyroid Nodule
A thyroid nodule is a discrete lesion within the thyroid gland that is radiologically distinct from the surrounding thyroid parenchyma. Most thyroid nodules are benign, with only 10% to 15% harboring cancer. This is a prospective study conducted at the department of Ear, Nose and Throat - Head and Neck Surgery (ENT-HNS) of Shree Birendra Hospital , a tertiary heath care centre of Nepal. Individuals visiting ENT-HNS outpatient department with thyroid nodules had undergone Ultrasonography (USG) of neck followed by Fine-Needle Aspiration Cytology (FNAC) from the thyroid nodules. USG was reported by Thyroid Imaging Reporting and Data System(TIRADS) and FNAC by Bethesda system. Thereafter patients were planned either for surgery either total thyroidectomy or hemithyroidectomy. Post operative histopathology was correlated with preoperative FNAC and USG reports.
Read the detailed description
The main objective of this prospective cohort study is to know the correlation between pre- operative Bethesda with post- operative histopathology , pre - operative TIRADS with post operative Histopathology and comparison of combined scoring of Bethesda and TIRADS with histopathology report. It is of utmost importance to deep dive into thyroid nodules workup to detect malignant nodules, as the management aspect of benign and malignant nodules has a vast difference. Thyroid ultrasonography is useful for risk stratification of nodules, and American College of Radiology Thyroid Imaging Reporting and Data System (ACR TI-RADS) classification provides recommendations for fine-needle aspiration cytology (FNAC) based on objective ultrasonography features of these nodules. To maintain uniformity in reporting system FNA sample are categorized according to the Bethesda system. Total 42 participants who met the inclusion criteria were included in the study. Statistical Analysis was done using Statistical Package for the Social Science (SPSS) version 25. Analysis was done in the form of percentage and proportion and represented as table wherever necessary. Spearman's correlation coefficient was used to evaluate the correlation between Bethesda and TIRADS. Bethesda and histopathology and TIRADS and Bethesda system. The P value was set at < 0.05 for statistical significance.
- Conditions
- Thyroid Nodule
- Keywords
- FNAC, TIRADS, Bethesda, Histopathology
- Medical subject headings
- Thyroid Nodule
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between Bethesda and TIRADS system
Correlation between Bethesda and TIRADS system in terms of number of participants belonging to each category
Measured: 6 months
Performance measure of Bethesda classification
Performance measure of Bethesda classification in terms of percentage
Measured: 6 months
Performance measure of TIRADS classification
Performance measure of TIRADS classification in terms of percentage
Measured: 6 months
Secondary outcomes (5)
Sex-wise Distribution of thyroid nodule
Sex-wise Distribution of thyroid nodule in percentage
Measured: 6 months
Percentage of participants as per TIRADS classification
Percentage of participants as per TIRADS classification
Measured: 6 months
Number of participants as per histopathological examination
Number of participants as per histopathological examination
Measured: 6 months
Number of participants as per Bethesda classification
Number of participants as per Bethesda classification
Measured: 6 months
Types of surgical procedures performed in terms of percentage
Types of surgical procedures performed in terms of percentage
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2024
- Study start20 Jun 2022
- Primary completion25 Nov 2022
- Study completion15 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tribhuvan University, Nepal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anupama Marasini, Tribhuvan University, Nepal
- Investigators
- Reeba Karki, MS, Principal investigator, Shree Birendra Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06391021
- Sponsor's protocol ID
- 628
- Acronym
- TIRADS
- Status last verified
- Apr 2024
- First submitted
- 25 Apr 2024
- Last updated
- 2 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share the individual participant data to protect the privacy of the participants.
Publications
Haugen BR, Alexander EK, Bible KC, Doherty GM, Mandel SJ, Nikiforov YE, Pacini F, Randolph GW, Sawka AM, Schlumberger M, Schuff KG, Sherman SI, Sosa JA, Steward DL, Tuttle RM, Wartofsky L. 2015 American Thyroid Association Management Guidelines for Adult Patients with Thyroid Nodules and Differentiated Thyroid Cancer: The American Thyroid Association Guidelines Task Force on Thyroid Nodules and Differentiated Thyroid Cancer. Thyroid. 2016 Jan;26(1):1-133. doi: 10.1089/thy.2015.0020.
PubMed 26462967
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Combined Scoring of Bethesda Cytology and TIRADS Ultrasound With Post- Operative Histopathology in Thyroid Nodule
- ClinicalTrials.gov ID
- NCT06391021
- Acronym / sponsor ID
- TIRADS / 628
- Conditions
- Thyroid Nodule
- Keywords
- FNAC, TIRADS, Bethesda, Histopathology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Tribhuvan University, NepalUniversity, hospital or other
- Study start
- 20 Jun 2022 (actual)
- Primary completion
- 25 Nov 2022 (actual)
- Study completion
- 15 Feb 2023 (actual)
- First posted
- 30 Apr 2024 (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.
A thyroid nodule is a discrete lesion within the thyroid gland that is radiologically distinct from the surrounding thyroid parenchyma. Most thyroid nodules are benign, with only 10% to 15% harboring cancer. This is a prospective study conducted at the department of Ear, Nose and Throat - Head and Neck Surgery (ENT-HNS) of Shree Birendra Hospital , a tertiary heath care centre of Nepal. Individuals visiting ENT-HNS outpatient department with thyroid nodules had undergone Ultrasonography (USG) of neck followed by Fine-Needle Aspiration Cytology (FNAC) from the thyroid nodules. USG was reported by Thyroid Imaging Reporting and Data System(TIRADS) and FNAC by Bethesda system. Thereafter patients were planned either for surgery either total thyroidectomy or hemithyroidectomy. Post operative histopathology was correlated with preoperative FNAC and USG reports.
Detailed description
The main objective of this prospective cohort study is to know the correlation between pre- operative Bethesda with post- operative histopathology , pre - operative TIRADS with post operative Histopathology and comparison of combined scoring of Bethesda and TIRADS with histopathology report. It is of utmost importance to deep dive into thyroid nodules workup to detect malignant nodules, as the management aspect of benign and malignant nodules has a vast difference. Thyroid ultrasonography is useful for risk stratification of nodules, and American College of Radiology Thyroid Imaging Reporting and Data System (ACR TI-RADS) classification provides recommendations for fine-needle aspiration cytology (FNAC) based on objective ultrasonography features of these nodules. To maintain uniformity in reporting system FNA sample are categorized according to the Bethesda system. Total 42 participants who met the inclusion criteria were included in the study. Statistical Analysis was done using Statistical Package for the Social Science (SPSS) version 25. Analysis was done in the form of percentage and proportion and represented as table wherever necessary. Spearman's correlation coefficient was used to evaluate the correlation between Bethesda and TIRADS. Bethesda and histopathology and TIRADS and Bethesda system. The P value was set at < 0.05 for statistical significance.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 66 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All the participants with thyroid nodules who met the inclusion criteria within the study period were enrolled in the study . Total 42 participants were included in the study.
Key inclusion criteria (1 listed)
- 1.Patients presenting to Ear Nose and Throat, Head and Neck Surgery Department with thyroid nodules undergoing hemithyroidectomy or total thyroidectomy within the study period
Key exclusion criteria (1 listed)
- 1.Patients refusing to give consent for the study. 2.Patients with already known case of thyroid malignancies proven by histopathological reports.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlation between Bethesda and TIRADS system
Time frame: 6 months
Correlation between Bethesda and TIRADS system in terms of number of participants belonging to each category
Performance measure of Bethesda classification
Time frame: 6 months
Performance measure of Bethesda classification in terms of percentage
Performance measure of TIRADS classification
Time frame: 6 months
Performance measure of TIRADS classification in terms of percentage
5 secondary outcomes
Sex-wise Distribution of thyroid nodule
Time frame: 6 months
Percentage of participants as per TIRADS classification
Time frame: 6 months
Number of participants as per histopathological examination
Time frame: 6 months
Number of participants as per Bethesda classification
Time frame: 6 months
Types of surgical procedures performed in terms of percentage
Time frame: 6 months
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 2 May 2024.
- Background: PubMed 26462967Haugen BR, Alexander EK, Bible KC, Doherty GM, Mandel SJ, Nikiforov YE, Pacini F, Randolph GW, Sawka AM, Schlumberger M, Schuff KG, Sherman SI, Sosa JA, Steward DL, Tuttle RM, Wartofsky L. 2015 American Thyroid Association Management Guidelines for Adult Patients with Thyroid Nodules and Differentiated Thyroid Cancer: The American Thyroid Association Guidelines Task Force on Thyroid Nodules and Differentiated Thyroid Cancer. Thyroid. 2016 Jan;26(1):1-133. doi: 10.1089/thy.2015.0020.
- Individual participant dataSharing planned: No. There is no plan to share the individual participant data to protect the privacy of the participants.
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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.
Reeba Karki, MS principal investigator
Shree Birendra Hospital
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 Tribhuvan University, Nepal at 1 site in Nepal.
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 2 May 2024. 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 Nepal. 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.
What does the primary outcome measure?
Correlation between Bethesda and TIRADS system (time frame: 6 months). The study lists 3 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 NCT06391021, which also lists 1 linked publication.
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 2 May 2024.