| CTRI Number |
CTRI/2025/07/091093 [Registered on: 17/07/2025] Trial Registered Prospectively |
| Last Modified On: |
16/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
An observational study of management and outcomes of goitre patients with intermediate microscopic category swellings. |
|
Scientific Title of Study
|
Evaluation and Outcomes of TBSRTC 3 Thyroid Nodules- An Observational
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 |
DR Punati Vishnu Nandan Naidu |
| Designation |
Junior resident |
| Affiliation |
Kasturba Medical College Manipal |
| Address |
Department of General Surgery,3rd floor smt.Sharadav Madhav Pai OPD, Kasturba Hospital, Manipal
Udupi
Udupi
KARNATAKA
576104
India |
| Phone |
9121458354 |
| Fax |
|
| Email |
vishnu.punati6@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr SS PRASAD |
| Designation |
Associate Dean Professor and Head of Department of General Surgery |
| Affiliation |
Kasturba Medical College |
| Address |
Department of General Surgery,3rd floor smt.Sharadav Madhav Pai OPD, Kasturba Hospital, Manipal
Udupi
Udupi
KARNATAKA
576104
India |
| Phone |
8073680789 |
| Fax |
|
| Email |
Prasad.ss@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.Sharadav Madhav Pai OPD, Kasturba Hospital, Manipal
Udupi
Udupi
KARNATAKA
576104
India |
| Phone |
9731243721 |
| Fax |
|
| Email |
pavan.bhat@manipal.edu |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Punati Vishnu Nandan Naidu |
| Address |
Department of General Surgery,3rd floor smt.Sharadav Madhav Pai OPD, Kasturba
Hospital, Manipal
Udupi
KARNATAKA
576104
India |
| Type of Sponsor |
Other [No cost involed as it is an observational study] |
|
|
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 Punati Vishnu Nandan Naidu |
Kasturba Medical College and Hospital |
3rd floor, Department of
General Surgery,
smt.Sharadav Madhav Pai
OPD, Kasturba
Hospital,Manipal-
576104,Udupi District,
Karnataka, INDIA
Udupi
KARNATAKA
Udupi
KARNATAKA |
9121458354
vishnu.punati6@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee 2 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C73||Malignant neoplasm of thyroid gland, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients diagnosed with Bethesda III (AUS/FLUS) thyroid nodules on fine-needle aspiration (FNA)
cytology.
2.Patient undergoing surgical intervention for Bethesda 3(AUS/FLUS)Thyroid nodule |
|
| ExclusionCriteria |
| Details |
1.Patients operated previously for a thyroid malignancy.
2.Patients with FNAC report other than BETHESDA 3 thyroid nodule. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
-To determine the final histopathological findings in Bethesda 3 thyroid nodule for patients who are undergoing surgical intervention.
|
1year 7months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
-To correlate FNAC reporting- Bethesda 3 (AUS/FLUS) thyroid nodule with ultrasound characteristics
(e.g. hypoechogenicity, irregular margins, microcalcification etc) TI-RADS classification. |
1year 7months |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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, observational, single centered study that will be conducted at Department of General Surgery, Department of Surgical Oncology, Department of Head and Neck Surgery and the 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 In- Patient 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 thyroid function tests which have been sent before surgery will be analyzed with FNAC, USG and final histopathological report. |