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CTRI Number  CTRI/2020/10/028359 [Registered on: 12/10/2020] Trial Registered Prospectively
Last Modified On: 16/06/2021
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Correlation of post-operative biopsy report of thyroid nodules with pre-operative scan and pathology findings 
Scientific Title of Study   Cytohistologic and sonographic correlation of thyroid nodules - A prospective study in a tertiary cancer centre 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sandeep Suresh 
Designation  Fellow 
Affiliation  Regional Cancer Centre Thiruvananthapuram 
Address  Department of Head and Neck Surgery Regional Cancer Centre Thiruvananthapuram

Thiruvananthapuram
KERALA
695011
India 
Phone  8129420999  
Fax    
Email  drsandeepsuresh@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Nebu Abraham George 
Designation  Associate Professor 
Affiliation  Regional Cancer Centre Thiruvananthapuram 
Address  Department of Head and Neck Surgery Regional Cancer Centre Thiruvananthapuram

Thiruvananthapuram
KERALA
695011
India 
Phone  9447020522  
Fax    
Email  georgeabe@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Sandeep Suresh 
Designation  Fellow 
Affiliation  Regional Cancer Centre Thiruvananthapuram 
Address  Department of Head and Neck Surgery Regional Cancer Centre Thiruvananthapuram

Thiruvananthapuram
KERALA
695011
India 
Phone  8129420999  
Fax    
Email  drsandeepsuresh@gmail.com  
 
Source of Monetary or Material Support  
Regional Cancer Centre Thiruvananthapuram 
 
Primary Sponsor  
Name  Regional Cancer Centre 
Address  Regional Cancer Centre Thiruvananthapuram Kerala 
Type of Sponsor  Research institution and hospital 
 
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 Sandeep Suresh  Regional Cancer Centre Thiruvananthapuram  Department of Head and Neck Surgery
Thiruvananthapuram
KERALA 
8129420999

drsandeepsuresh@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Scientific Review Committee Regional Cancer Centre Thiruvananthapuram  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C73||Malignant neoplasm of thyroid gland,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Month(s)
Age To  70.00 Year(s)
Gender  Female 
Details  1. Treatment naive cases
2. Only cases which undergo thyroidectomy in our institution 
 
ExclusionCriteria 
Details  The cases excluded were thyroid nodules less than 1cm with no sonological features of malignancy and cases with a previous history of thyroid surgery. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To correlate Fine Needle Aspiration Cytology and Ultrasonography with final histopathology of thyroid cancers  6 months 
 
Secondary Outcome  
Outcome  TimePoints 
To determine the concordance of Ultrasound TIRADS Bethesda system of Cytology and final Histopathology report  6 months 
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
Final Enrollment numbers achieved (Total)= "150"
Final Enrollment numbers achieved (India)="150" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/10/2020 
Date of Study Completion (India) 31/12/2020 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="5"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
Published 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  

Background: Fine needle aspiration cytology (FNAC) reduces the number of unnecessary thyroid surgeries for patients with benign nodules and appropriately triages patients with thyroid cancer to appropriate treatment.

 

Methods: This was a observational study done on cases presenting with clinical suspicion of thyroid malignancy which underwent ultrasonography followed by FNAC of thyroid nodule. Ultrasonographic characterization of nodules was based on Thyroid Imaging Reporting And Data System (TIRADS) and cytology reporting was based on Bethesda system. All recruited patients underwent thyroidectomy. Pre-operative cytology and ultrasonography features were compared with final histopathology report.

 

Results: In our study, Bethesda system of cytology reporting for thyroid nodules had a better sensitivity, specificity and diagnostic accuracy than TIRADS system of ultrasound reporting. Bethesda system in FNAC had a larger area under the ROC curve (0.91) as compared to ultrasound TIRADS (0.70). Malignancy rate of TIRADS 5 nodules was 97.1% with significant p value (0.022). 100% of Bethesda VI lesions were malignant according to final histopathology report. Ultrasound TIRADS could pre-operatively predict malignancy in 63.6% of indeterminate thyroid nodules with confirmed malignancy in post-operative histopathology. The overall concordance of ultrasound TIRADS, Bethesda system and histopathology was 69.8%.

 

Conclusions: Higher TIRADS and Bethesda scoring among thyroid nodules was associated with increased risk of malignancy. Our study showed good concordance among US TIRADS, Bethesda system of cytology and final histopathology of thyroid nodules. US TIRADS was a good predictor of malignancy in indeterminate thyroid nodules.


 
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