| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C73||Malignant neoplasm of thyroid gland, |
|
|
Intervention / Comparator Agent
|
|
|
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. |