| CTRI Number |
CTRI/2024/07/071742 [Registered on: 31/07/2024] Trial Registered Prospectively |
| Last Modified On: |
31/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic |
| Study Design |
Other |
|
Public Title of Study
|
Accuracy of Ultrasound guided minimally invasive sampling of Thyroid Nodules. |
|
Scientific Title of Study
|
Diagnostic Accuracy of USG guided FNAC of Thyroid Nodules- Prospective Study in a Tertiary Care Hospital. |
| 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 Suman Kumar Ankathi |
| Designation |
Associate Professor, Department of Radiodiagnosis |
| Affiliation |
Tata Memorial Hospital, Mumbai |
| Address |
TATA MEMORIAL HOSPITAL
Dr. E Borges Road, Parel, Mumbai - 400 012
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9619159007 |
| Fax |
|
| Email |
drsumankumar007@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Urvashi Uppal |
| Designation |
Junior Reisdent |
| Affiliation |
ata Memorial Hospital, Mumbai |
| Address |
TATA MEMORIAL HOSPITAL
Dr. E Borges Road, Parel, Mumbai - 400 012
Mumbai
MAHARASHTRA
400012
India |
| Phone |
7838962736 |
| Fax |
|
| Email |
uppal.urvashi7@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Urvashi Uppal |
| Designation |
Junior Reisdent |
| Affiliation |
ata Memorial Hospital, Mumbai |
| Address |
TATA MEMORIAL HOSPITAL
Dr. E Borges Road, Parel, Mumbai - 400 012
MAHARASHTRA
400012
India |
| Phone |
7838962736 |
| Fax |
|
| Email |
uppal.urvashi7@gmail.com |
|
|
Source of Monetary or Material Support
|
| Tata Memorial Hospital
E Borges Road, Parel, Mumbai - 400 012 India. |
|
|
Primary Sponsor
|
| Name |
Dr Suman Kumar Ankathi |
| Address |
Tata Memorial Hospital
Dr E Borges Road, Parel, Mumbai- 400012 |
| Type of Sponsor |
Other [Self] |
|
|
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 Urvashi Uppal |
Tata Memorial Hospital, Mumbai |
Room no 72, Main building
Ground floor
Tata Memorial Hospital, Mumbai
Mumbai
MAHARASHTRA |
7838962736
uppal.urvashi7@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee-I |
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 |
Neck Ultrasound followed by USG guided FNAC of thyroid nodules. |
A baseline USG neck would be performed in all the referred cases of suspected thyroid nodules and findings would be reported in terms of TIRADS categories. USG guided FNAC would be performed in those nodules which warrant further investigation in terms of cytology. The frequency of USG guided FNAC of thyroid nodules is approximately 15 cases per week (60 cases a month). Data collection would continue for a duration of 2 years.
These cases would also be followed up and final HPR would be obtained in those undergoing surgery and would be considered gold standard. |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient undergoing USG guided FNAC of thyroid nodules at TMH.
2. Availability of USG images on PACS/reports on EMR.
3. Clinical and cytopathological data on EMR. |
|
| ExclusionCriteria |
| Details |
Exclusion criteria:
1. Incomplete medical records or non availability of USG reports.
2. Patients who have undergone USG guided FNAC outside TMC.
3. Patients who have been lost to follow up.
4. Patients who have undergone thyroid surgery in the past. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Assess efficacy of USG guided FNAC in obtaining diagnostic samples from thyroid nodules in terms of percentage of total FNACs performed taking Bethesda 1 as non-diagnostic/inadequate and Bethesda 2-6 as diagnostic/adequate.
2. To evaluate the accuracy of USG guided FNAC in predicting the final HPR in patients undergoing surgery in terms of True Positive, True Negative, False Positive and False Negative. |
1. At the time of reporting of FNAC samples which is roughly one week from the date of sample collection.
2. After obtaining final histopathology report at the time of surgery. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess performance of TIRADS classification on a prospectively maintained database, in risk
stratification of thyroid nodules in terms of correlation of final HPR result in different TIRADS categories. |
After receiving final HPR (about 1 week after surgery), the baseline TIRADS score at the time of diagnostic workup would be correlated to the final HPR result. All cases would be followed up for surgical HPR at regular 1 week intervals. |
|
|
Target Sample Size
|
Total Sample Size="1000"
Sample Size from India="1000"
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)
|
12/08/2024 |
| 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="2"
Months="0"
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 is a prospective audit assessing the efficacy and diagnostic accuracy of USG guided FNAC of thyroid nodules that will be conducted in 1000 patients in Tata Memorial Hospital, Mumbai over a period of 2 years. The primary aim is to assess efficacy of USG guided FNAC in obtaining diagnostic samples from thyroid nodules and to evaluate the accuracy of USG guided FNAC in predicting the final HPR in patients undergoing surgery. Secondary aim is to assess performance of TIRADS classification on a prospectively maintained database, in risk stratification of thyroid nodules and to study causes of, and possibility of reducing limitations and increasing accuracy of USG guided FNAC. |