| CTRI Number |
CTRI/2024/03/064048 [Registered on: 13/03/2024] Trial Registered Prospectively |
| Last Modified On: |
26/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective Comparative study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
USG vs Frozen section for intraoperative deep margins in carcinoma tongue |
|
Scientific Title of Study
|
Comparing Ex-Vivo Ultrasound aided and Frozen section analysis of deep margins with Final Histopathology in T1-T4 Carcinoma Tongue: A Prospective 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 |
Nivedhitha Murugesan |
| Designation |
Junior Resident |
| Affiliation |
AIIMS NEW DELHI |
| Address |
Department of Otorhinolaryngology and Head & Neck Surgery, Room no. 4057, ENT Office, 4th Floor, Teaching Block, AIIMS, New Delhi, India.
New Delhi
DELHI
110029
India |
| Phone |
9150054466 |
| Fax |
|
| Email |
nivedhitham2016@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rajeev Kumar |
| Designation |
Additional Professor |
| Affiliation |
AIIMS NEW DELHI |
| Address |
Department of Otorhinolaryngology and Head & Neck Surgery, Room no. 4057, ENT Office, 4th Floor, Teaching Block, AIIMS, New Delhi, India.
New Delhi
DELHI
110029
India |
| Phone |
9968569892 |
| Fax |
|
| Email |
rajeev9843@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Nivedhitha Murugesan |
| Designation |
Junior Resident |
| Affiliation |
AIIMS NEW DELHI |
| Address |
Department of Otorhinolaryngology and Head & Neck Surgery, Room no. 4057, ENT Office, 4th Floor, Teaching Block, AIIMS, New Delhi, India.
New Delhi
DELHI
110029
India |
| Phone |
9150054466 |
| Fax |
|
| Email |
nivedhitham2016@gmail.com |
|
|
Source of Monetary or Material Support
|
| AIIMS NEW DELHI Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East, New Delhi, Delhi 110029 |
|
|
Primary Sponsor
|
| Name |
AIIMS NEW DELHI |
| Address |
Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East, New Delhi, Delhi 110029 |
| 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 Nivedhitha Murugesan |
AIIMS NEW DELHI |
Department of Otorhinolaryngology and Head & Neck Surgery, Room no. 4057, ENT Office, 4th Floor, Teaching Block, AIIMS, New Delhi, India.
New Delhi
DELHI |
9150054466
nivedhithamurugesan2016@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee for biomedical and Health Research, AIIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C021||Malignant neoplasm of border of tongue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
7.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient planned for surgery with biopsy proven Squamous Cell Carcinoma Lateral border of Tongue T1-T4 anyN M0.
2.Patient giving consent to participate in study.
|
|
| ExclusionCriteria |
| Details |
1.Patient who is not willing to participate in the study.
2.Patient is unfit for surgery under general anesthesia.
3.Patients of Carcinoma Tongue with metastasis M1.
4.Patients of Carcinoma Tongue any stage who have undergone Neoadjuvant Chemotherapy/Post op Chemotherapy and Radiotherapy. |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To determine accuracy of USG aided ex-vivo deep margin assessment with final histopathology.
2.To determine accuracy of frozen section analysis for deep margin assessment with final histopathology. |
2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare both techniques USG guided & Frozen section with respect to final histopathology |
2 weeks |
|
Target Sample Size
Modification(s)
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
25/03/2024 |
| 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) |
Open to Recruitment |
|
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
|
The preferred modality of treatment for squamous cell carcinoma tongue is surgical resection. Free margin status >5mm is essential for local control and disease free survival. Submucosal or deep margins are often inadequate. Because patients with involved and close margins may require additional surges or adjuvant (chemo)radiotherapy, there is a need for technology that can provide real time, intraoperative feedback on margins. In this trial, we are going to determine the accuracy and consistency between ex vivo ultrasound aided and frozen section analysis of resected specimen to final histopathology in oral tongue squamous cell carcinoma. |