FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/05/067641 [Registered on: 20/05/2024] Trial Registered Prospectively
Last Modified On: 17/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Diagnostic 
Study Design  Single Arm Study 
Public Title of Study   A study to test reliability of ultrasound based AMERICAN COLLEGE OF RADIOLOGY THYROID IMAGING REPORTING AND DATA SYSTEM (ACR TI-RADS) in separating benign vs cancerous thyroid lesions . 
Scientific Title of Study   Reliability of ultrasound based AMERICAN COLLEGE OF RADIOLOGY THYROID IMAGING REPORTING AND DATA SYSTEM (ACR TI-RADS) in segregating benign and malignant thyroid lesions and its cytopathological correlation– a hospital based study. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sonia D kaur 
Designation  Head of department Radiology  
Affiliation  Fortis hospital 
Address  Fortis escorts neelam chowk NIT faridabad

Faridabad
HARYANA
121001
India 
Phone  9810220966  
Fax    
Email  Radiology.fbd@fortishealthcare.com  
 
Details of Contact Person
Scientific Query  
Name  Sonia D kaur 
Designation  Head of department Radiology  
Affiliation  Fortis hospital 
Address  Fortis escorts neelam chowk NIT faridabad

Faridabad
HARYANA
121001
India 
Phone  9810220966  
Fax    
Email  Radiology.fbd@fortishealthcare.com  
 
Details of Contact Person
Public Query  
Name  Sonia D kaur 
Designation  Head of department Radiology  
Affiliation  Fortis hospital 
Address  Fortis escorts neelam chowk NIT faridabad

Faridabad
HARYANA
121001
India 
Phone  9810220966  
Fax    
Email  Radiology.fbd@fortishealthcare.com  
 
Source of Monetary or Material Support  
Fortis hospital faridabad 
 
Primary Sponsor  
Name  Fortis hospital faridabad 
Address  Neelam chowk NIT faridabad 121001 
Type of Sponsor  Private hospital/clinic 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Shubhkarman singh  Fortis hospital faridabad  Reporting Room No 1 ,Department of radiology , fortis hospital ,Neelam chowk NIT faridabad
Faridabad
HARYANA 		 7986359268

Sartaj727825@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E041||Nontoxic single thyroid nodule,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  (ACR TIRADS) American College of radiology Thyroid imaging ,reporting and data systems .  Comparing American college of radiology thyroid imaging reporting and data systems recommendations in predicting nature of thyroid nodules and comparing it with cytopathogical study post ultrasound guided Fine needle aspiration. 
Intervention  (US FNAC) Ultrasound guided fine needle aspiration and its cytopathological study .  Ultrasound guided fine needle aspiration of thyroid nodules and its cytopathological study. 
 
Inclusion Criteria  
Age From  0.00 Day(s)
Age To  99.00 Year(s)
Gender  Both 
Details  All patients with thyroid nodules 
 
ExclusionCriteria 
Details  Subjects with normal thyroid scans
Subjects not option for FNAC study 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Benign and malignant cytology of thyroid nodules  18 months 
 
Secondary Outcome  
Outcome  TimePoints 
Reliability of ACR TIRADS in dictating management of thyroid nodules  18 months 
 
Target Sample Size   Total Sample Size="46"
Sample Size from India="46" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   28/05/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response - Informed Consent Form
    Response (Others) -  Subject Information sheet
  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [Sartaj727825@gmail.com].

  6. For how long will this data be available start date provided 05-05-2024 and end date provided 05-05-2027?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Thyroid nodules are “discrete lesions within the thyroid gland, radiologically distinct from surrounding thyroid parenchyma.”1 They are commonly detected lesions on clinical examination and ultrasonography with detection rates approaching ~50-60%.2 With new advances in diagnostics prevelance of thyroid nodules had reached 67%.3

 

Ultrasonography is the preferred modality for the evaluation of thyroid nodules. Cytopathological correlation using Ultrasound-guided Fine needle aspiration cytology (US-FNAC) is mostly performed to establish the benign or malignant status of the thyroid nodule. Complex and varied features of thyroid nodules warranted the need to constitute various risk stratification systems to classify, standardize, and appropriate management of thyroid nodules. Amongst various classification systems, the American College of Radiology Thyroid Imaging Reporting and Data System (ACR TI-RADS) is one of the most widely accepted system in contemporary medicine practice globally.4

 

ACR TI-RADS was introduced by Horvath et al. in the year 2009.4 Scoring is determined from five categories of ultrasound findings(figure 1). The higher the cumulative score, the higher the TR (TI-RADS) level and the likelihood of malignancy. Our study will help provide a theoretical evidence basis for testing the reliability of ACR TI-RADS in classifying thyroid nodules.

 
Close