| CTRI Number |
CTRI/2025/07/091215 [Registered on: 21/07/2025] Trial Registered Prospectively |
| Last Modified On: |
19/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparing blood inflammation levels in cancerous and non cancerous thyroid growths |
|
Scientific Title of Study
|
A Comparative study of Systemic immune-inflammatory index in Benign and Malignant thyroid lesions |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Bhavya Kalra |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of General Surgery, 3rd Floor, Smt. Sharada Madhav Pai OPD, Kasturba Hospital, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9810807495 |
| Fax |
|
| Email |
bhavya.kmcmpl2024@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr K Rajgopal Shenoy |
| Designation |
Professor and Head of unit |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of General Surgery, 3rd Floor, Smt. Sharada Madhav Pai OPD, Kasturba Hospital, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9845243460 |
| Fax |
|
| Email |
rajgopal.shenoy@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pavan M Bhat |
| Designation |
Assistant Professor |
| Affiliation |
Kasturba Medical College |
| Address |
Department of General Surgery, 3rd Floor, Smt. Sharada Madhav Pai OPD, Kasturba Hospital, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9731243720 |
| Fax |
|
| Email |
pavan.bhat@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba medical college and hospital |
|
|
Primary Sponsor
|
| Name |
Dr Bhavya Kalra |
| Address |
Department of General Surgery, 3rd floor, Smt Sharada Madhav Pai OPD, Kasturba Hospital, Manipal |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Bhavya Kalra |
KASTURBA HOSPITAL |
Room number 8 , 3rd floor, Department of General Surgery, Smt Sharada Madhav pai OPD block, Eshwar Nagar, Manipal, Karnataka 576104
Udupi
KARNATAKA |
09810807495
bhavya.kmcmpl2024@learner.manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical Collega and Kasturba Hospital Institutional Ethics Comimittee - 2 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E079||Disorder of thyroid, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing USG Neck (with TIRADS score) and FNAC (with Bethesda score)
All patients from the above who undergo thyroidectomy (Hemi or Total)
|
|
| ExclusionCriteria |
| Details |
Patients with Active or chronic infection
Patients with diffuse toxic goitre
Immunocompromised patients, patients with autoimmune diseases
Patients who underwent head and neck radiation
Pregnant patients
Patients previously underwent thyroid surgery
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Create a cut off value of SII with optimal sensitivity and specificity to aid in differentiating benign and malignant thyroid lesions (using an ROC curve)
|
At index presentation
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Assessing the utility of SII in inderminate lesions (Bethesda 3,4 & TIRADS 3)
|
At index presentation |
|
|
Target Sample Size
|
Total Sample Size="88"
Sample Size from India="88"
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)
|
01/08/2025 |
| 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="8"
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 - NO
|
|
Brief Summary
|
This study is a prospective longitudinal study that will be conducted at Department of surgery, Department of Surgical Oncology, Department of Head and neck surgery, Department of ENT, Kasturba Hospital, Manipal. The study will undergo approval by the Institutional Ethics Committee. Informed consent will be taken from the participants at the time of enrolment on IP basis in the ward. Study population will include patients with thyroid lesions and relevant history and examination will be conducted to screen for inclusion and exclusion criteria. The patient will have undergone diagnostic USG (with TIRDAS scoring) and FNAC (with Bethesda classification). The routine hemogram which has been sent before surgery will be analyzed with FNAC, USG and final histopathological report. |