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CTRI Number  CTRI/2024/10/075913 [Registered on: 25/10/2024] Trial Registered Prospectively
Last Modified On: 11/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   To see immunohistochemistry marker positivity in patients with oral cavity cancer in a hospital set up for better understanding of the cancer and plan the best treatment accordingly. 
Scientific Title of Study   Expression of p16 and ALK on Immunohistochemistry in patients with oral cavity squamous cell carcinoma in a tertiary care hospital 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
AIIMSG/IEC/M5/P5/2024 DATED MAY 31 2024  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shuvankar Srutikar  
Designation  Postgraduate Resident 
Affiliation  All India Institute of Medical Sciences Guwahati 
Address  Department of Pathology and Lab Medicine All India Institute of Medical Sciences Changsari Guwahati

Kamrup
ASSAM
781101
India 
Phone  7002352213  
Fax    
Email  shuvankarsrutikar@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr SP Sinhasan 
Designation  Professor and Head of department of Pathology and Lab Medicine 
Affiliation  All India Institute of Medical Sciences Guwahati 
Address  Department of Pathology and Lab Medicine All India Institute of Medical Sciences Changsari Guwahati

Kamrup
ASSAM
781101
India 
Phone  9442551998  
Fax    
Email  spsinhasan@aiimsguwahati.ac.in  
 
Details of Contact Person
Public Query  
Name  Dr SP Sinhasan 
Designation  Professor and Head of department of Pathology and Lab Medicine 
Affiliation  All India Institute of Medical Sciences Guwahati 
Address  Department of Pathology and Lab Medicine All India Institute of Medical Sciences Changsari Guwahati

Kamrup
ASSAM
781101
India 
Phone  9442551998  
Fax    
Email  spsinhasan@aiimsguwahati.ac.in  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences Guwahati Assam India Pin code- 781101 
 
Primary Sponsor  
Name  Dr Shuvankar Srutikar 
Address  Department of Pathology and Lab Medicine All India Institute of Medical Sciences Guwahati 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Shuvankar Srutikar  All India Institute of Medical Sciences Guwhati  Histopathology laboratory, Department of Pathology and Lab Medicine, All India Institute of Medical Sciences Guwhati
Kamrup
ASSAM 		 7002352213

shuvankarsrutikar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics Committee AIIMS Guwahati  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C148||Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Not Applicable  Not Applicable 
 
Inclusion Criteria  
Age From  0.00 Day(s)
Age To  90.00 Year(s)
Gender  Both 
Details  All the histopathologically diagnosed case of Squamous Cell Carcinoma of oral cavity 
 
ExclusionCriteria 
Details  1.Insufficient material on tissue block for Immunohistochemistry

2.Already treated cases and relapse cases of oral cavity squamous cell carcinoma 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Proportion of HPV in oral cavity squamous cell carcinoma (OSCC) specimens as indicated by p16 immunohistochemistry positivity  Baseline 
 
Secondary Outcome  
Outcome  TimePoints 
ALK overexpression as a marker to identify Oral cavity Squamous Cell Carcinoma patients   Baseline 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   01/11/2024 
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 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 titled "Expression of p16 and ALK on Immunohistochemistry in patients with oral cavity squamous cell carcinoma in a tertiary care hospital" is a single centered, cross-sectional, observational study to be held at Department of Pathology and Lab Medicine, AIIMS Guwahati for a period of two years.
The study aims to detect expression of p16 and ALK protein in oral cavity squamous cell carcinoma. After informed consent and filling up of the patient proforma, all oral cavity carcinoma samples received in the histopathology lab will be carefully collected, labelled, and left to fixate overnight in 10% neutral buffered formalin. The following day, these samples will undergo grossing, where  the representative tissue sections will be placed into individual cassettes for processing. These cassettes will then undergo dehydration, clearing, and wax impregnation in a tissue processor. The processed tissues will be embedded in molten wax for block preparation and sliced into 3–4-micron sections using a microtome, which will be then mounted onto slides.

A total of eighty slides will be stained with haematoxylin and eosin (H&E) for histological grading and evaluation. Additionally, slides for immunohistochemistry (IHC) will be pre-coated with Poly-L-Lysine and stained with a specific mouse monoclonal antibody to p16. Carcinoma Cervix serves as the positive control, while staining without the primary antibody serves as the negative control. Microscopically normal appearing oral epithelial tissue sections expressing ALK protein will be used as positive controls for ALK staining.

After xylene immersion, slides will be mounted with a coverslip using Dibutylphthalate Polystyrene Xylene (DPX). H&E, p16 and ALK IHC staining procedures will be carried out and mounted accordingly.

Experienced pathologists will examine stained slides under a microscope, recording the extent and intensity of staining to provide quantitative and qualitative data on p16 and ALK expression. Representative fields will be captured in images for records and further analysis. The study does not involve any intervention or randomization.
Confidentiality of subjects would be maintained as per ICMR Guidelines. Both Participant Information Sheet and Informed Written consent will be in English, Hindi and Assamese language (language preferred by the participant). The estimated sample size of the study is 80. Data analysis for the study will be conducted using SPSS version 29. Descriptive statistics such as mean (standard deviation, SD) or median (interquartile range, IQR) will be calculated for continuous variables. For categorical variables, including stage of cancer, histological grade, and p16 expression (categorized as positive or negative), ALK expression (categorized as positive or negative), frequencies and percentages will be used. The proportion of p16 and ALK positive cases will be expressed as a percentage with 95% confidence interval. The study involves less than minimal risk. There is no conflict of interest. 
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