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CTRI Number  CTRI/2017/08/009497 [Registered on: 25/08/2017] Trial Registered Retrospectively
Last Modified On: 30/06/2017
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   Ultrasound for thyroid nodule evaluation. 
Scientific Title of Study   The Diagnostic Performance of Thyroid Multimodal- imaging Comprehensive Risk Stratification Scoring (TMC-RSS) In Characterizing Thyroid Nodules. 
Trial Acronym  TMC-RSS 
Secondary IDs if Any  
Secondary ID  Identifier 
Version No 1.0 dated 19/02/2016  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Abhishek Mahajan 
Designation  Assistant professor Department of Radio-diagnosis 
Affiliation  Tata Memorial Hospital 
Address  Room no 125, Ground floor, Main building Tata memorial Hospital Dr. E. Borges Road, Parel, Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  9920210811  
Fax    
Email  drabhishek.mahajan@yahoo.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Abhishek Mahajan 
Designation  Assistant professor Department of Radio-diagnosis 
Affiliation  Tata Memorial Hospital 
Address  Room no 125, Ground floor, Main building Tata Memorial Hospital Dr. E. Borges Road, Parel, Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  9920210811  
Fax    
Email  drabhishek.mahajan@yahoo.in  
 
Details of Contact Person
Public Query
 
Name  Dr Abhishek Mahajan 
Designation  Assistant professor Department of Radio-diagnosis 
Affiliation  Tata Memorial Hospital 
Address  Room no 125, Ground floor, Main building Tata Memorial Hospital Dr. E. Borges Road, Parel, Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  9920210811  
Fax    
Email  drabhishek.mahajan@yahoo.in  
 
Source of Monetary or Material Support  
Tata Memorial Hospital Dr. E. Borges Road, Parel, Mumbai  
 
Primary Sponsor  
Name  NA 
Address  Na 
Type of Sponsor  Other [NA] 
 
Details of Secondary Sponsor  
Name  Address 
Na  NA 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Abhishek Mahajan  Tata MemorialHospital  Room No 125 Dept of Radiology Main Building Gr floor, Tata Memorial Hospital,Parel, Mumbai
Mumbai
MAHARASHTRA 
9920210811

drabhishek.mahajan@yahoo.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics comittee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Patients referred for USG of the thyroid to TMC and Will undergo FNAC/ histopathology diagnosis after USG.,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Patients referred for USG of the thyroid.
Patient Will undergo FNAC/ histopathology diagnosis after USG. 
 
ExclusionCriteria 
Details  FNAC/ Histopathology not available 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To create an algorithm (TMC-RSS) using US features in combination with colour Doppler, elastography
features in combination with colour

Doppler, elastography. 
at the end of study
 
 
Secondary Outcome  
Outcome  TimePoints 
To Test TMC-RSS diagnostic performance to optimize diagnostic and therapeutic management in case of nodules/ focal lesions in thyroid.  after completion of study 
 
Target Sample Size   Total Sample Size="400"
Sample Size from India="400" 
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   N/A 
Date of First Enrollment (India)   06/06/2016 
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="2"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   NA 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  
Thyroid nodules are a common finding in the general population, and their detection is

increasing with the widespread use of ultrasound (US). The prevalence of thyroid

nodularity varies from 19% to 67%, and increases with age, affecting about 50% of the

population older than 40 years of age. The clinical significance of thyroid nodules relates to

the need to exclude thyroid cancer, which is found in 5–15% of cases, depending on sex,

age, and exposure to other risk factors. The incidence of thyroid cancer has increased about

fivefold in the last 50 years, mostly due to small papillary thyroid cancers, the most

indolent form of thyroid cancer.

Sonographic patterns such as hypoechogenicity, blurred or spiculated margins, spot

microcalcification, and intranodular vascularity are characteristics of malignant nodules,

but they yield a wide range of sensitivities (55–95%) and specificities (52–81%) for

diagnosis as malignant or benign. However, there is no information about the probability of

the US features associated with malignancy and which combination would be more

clinically useful. Diagnostic sensitivity ranges from 26.5% to 87.1% for hypoechogenicity,

54.3% to 74.3% for intranodular vascularity, and 26.1% to 59.1% for microcalcifications,

whereas specificity ranges from 43.4% to 94.3%, 78.6% to 80.8%, and 85.8% to 95%,

respectively

Fine-needle aspiration cytology (FNAC) is a standard method for triaging thyroid nodules

to surgery or clinical follow-up, and, with FNAC, the number of unnecessary surgeries has

decreased. The main limitation of FNAC, however, is nondiagnostic or unsatisfactory

results. According to the Bethesda System for Reporting Thyroid Cytopathology, a sample

is considered nondiagnostic or unsatisfactory when the specimen shows obscuring blood,

overlying thick smears, air drying of alcohol-fixed smears, or an inadequate number of

follicular cells. According to the Bethesda system, nondiagnostic results should ideally be

limited to less than 10% of all thyroid FNACs, but the rates of nondiagnostic results are

reported to be as high as 21%. Some authors have demonstrated that the best option for

reducing nondiagnostic results is on-site cytologic assessment. However, even with on-site

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Protocol Version 1.0 dated 19.02.2016

assessment by cytopathologists, the prevalence of nondiagnostic results has still been

reported to be 10.7%.

Cytologic examination of thyroid nodules by FNA is diagnostic method for differentiating

benign from malignant nodules with reported sensitivity to be 60–98% and specificity,

54–90%. The risk of malignancy in a nodule reported as malignant or suspicious for

malignancy at FNAC is 97%–99% and 60%–75%, respectively. The accuracy of US-guided

FNAC (68%) is higher than that of palpation-guided FNAC (48%)

The main diagnostic method used is invasive FNA and

– 30% of FNA samples from thyroid nodules are not conclusive,

• 10–15% of FNA samples yielding non-diagnostic results

• 10–20% yielding indeterminate results.

– 5% false-negative rate

The thyroid imaging reporting and data system (TIRADS) developed by Kwak et al can help

stratify thyroid nodules according to malignancy risk by using the number of suspicious

ultrasonography (US) features such as solidity, hypoechogenicity or marked

hypoechogenicity, microlobulated or irregular margins, microcalcifications, and taller-

than-wide shape. TIRADS can help accurately predict malignancy and can be easily applied

in clinical practice owing to its simplicity. However, this reporting system has not been

applied to thyroid nodules with nondiagnostic results at cytologic examination, even when

it can be used in the continuous risk stratification of nodules in this category after FNAC.
 
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