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CTRI Number  CTRI/2025/01/079571 [Registered on: 27/01/2025] Trial Registered Prospectively
Last Modified On: 01/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   To examine how useful PD-L1 (Programmed Cell Death Ligand 1) is as a marker for understanding tumor behavior in histopathological confirmed cases of oral squamous cell carcinoma (OSCC) patients and using anti-PD-L1 antibodies as effective immunotherapy for OSCC patients. 
Scientific Title of Study   To study the utility of PDL1(Programmed Cell Death Ligand One) expression as a immunohistochemical marker for assessing tumor behavior in comparison to histopathological grading and TNM staging in oral squamous cell carcinoma patients. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shailly Tiwari 
Designation  PG Student 
Affiliation  Datta Meghe Institute of Higher Education and Research(DMIHER) 
Address  Department of Pathology,Jawaharlal Nehru Medical College,Datta Meghe Institute of Higher Education and Research(DMIHER), Meghe, Sawangi, Wardha, Maharashtra 442107

Wardha
MAHARASHTRA
442107
India 
Phone  9428167252  
Fax    
Email  shaillysid@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Samarth Shukla 
Designation  Professor and Vice Dean 
Affiliation  Datta Meghe Institute of Higher Education and Research(DMIHER) 
Address  Department of Pathology,Jawaharlal Nehru Medical College,Datta Meghe Institute of Higher Education and Research(DMIHER), Meghe, Sawangi, Wardha, Maharashtra 442107

Wardha
MAHARASHTRA
442107
India 
Phone  8830267710  
Fax    
Email  samarth21174@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Shailly Tiwari 
Designation  PG Student 
Affiliation  Datta Meghe Institute of Higher Education and Research(DMIHER) 
Address  Department of Pathology,Jawaharlal Nehru Medical College,Datta Meghe Institute of Higher Education and Research(DMIHER), Meghe, Sawangi, Wardha, Maharashtra 442107

Wardha
MAHARASHTRA
442107
India 
Phone  9428167252  
Fax    
Email  shaillysid@gmail.com  
 
Source of Monetary or Material Support  
1)Datta Meghe Institute of Higher Education and Research (DMIHER),Meghe,Sawangi,Wardha,Maharashtra, pincode - 442107, India 2) Indian Council of Medical Research II Floor of Nirmal Bhawan, ICMR Complex, Poojanhalli Road, Off NH-7, Adjacent to Trumpet Flyover of BIAL Kannamangala, Bangalore - 562 110, India.  
 
Primary Sponsor  
Name  Datta Meghe Institute of Higher Education and Research (DMIHER) 
Address  Datta Meghe Institute of Higher Education and Research (DMIHER),Meghe,Sawangi,Wardha,Maharashtra 442107 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
Indian council for Medical Research  New Delhi 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Shailly R Tiwari  Acharya Vinoba Bhave Rural Hospital campus  Department of Pathology,Jawaharlal Nehru Medical College,Datta Meghe Institute of Higher Education and Research(DMIHER), Meghe, Sawangi, Wardha, Maharashtra 442107
Wardha
MAHARASHTRA 
09428167252

shaillysid@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Datta Meghe Institute of Higher Education and Research Institutional Ethics Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C00-C14||Malignant neoplasms of lip, oral cavity and pharynx,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1)Histo pathologically confirmed case of oral squamous cell carcinoma
2)All operated cases of Oral squamous cell carcinoma
3)All patients with oral squamous cell carcinoma arising Denovo
4)All cases with Composite resection of lesion, suitable Modified radical neck dissection (MRND), reconstruction with suitable flap` 
 
ExclusionCriteria 
Details  1)All cases of malignancy other than oral squamous cell carcinoma.
2)All cases of non - neoplastic lesions of oral cavity
3)Cases of recurrence.
4)Cases with previous history of chemotherapy and radiotherapy
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Conclusions will be drawn from the results obtained from IHC study using PDL1 for detecting its expression and correlate with the molecular subtypes of the oral squamous cell carcinoma.  2 years  
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="94"
Sample Size from India="94" 
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)   06/02/2025 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details
Modification(s)  
N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  

 Aim:To study the utility of PDL1(Programmed Cell Death Ligand One) expression as a immunohistochemical marker for assessing tumor behavior in comparison to histopathological grading and TNM staging in oral squamous cell carcinoma patients.

Objectives:

1.     To confirm already diagnosed cases of oral squamous cell carcinoma

2.     To evaluate PDL1 expression in oral squamous cell carcinoma.

3.     To compare PDL1 expression in oral squamous cell carcinoma with the grade and TNM staging of oral squamous cell carcinoma

Background :

The incidence of head & neck tumours is increasing worldwide. One of the most prevalent cancers worldwide is the oral cancer. Every year, an estimate 405,000 new cases of oral cancer are projected globally; the countries with the highest rates are Bangladesh, Bangladesh, India, Sri Lanka, Hungary, and France. It’s predicted that 66,650 new cases occur annually in the European Union. Oral cavity, salivary glands, and pharynx are all impacted by oral carcinoma. They are a major cause of death in developing nations as they are associated with serious health problems.

The three primary risk factors for carcinoma are tobacco usage, alcohol use, along with the consumption of betel nuts. Patients on immunosuppressive medication, receiving organ transplants, and those with HIV are more likely to acquire OSCC (oral squamous cell carcinoma).

OSCC is indicated by a reddish-white lesion having uneven surface but well-defined margins. Early lesions are usually painless. As they develop, some may produce nodularity, ulceration, and discomfort. One notable characteristic is presence of an ulcer that is difficult to palpate and has uneven edges.
One significant development in the management of OSCC is immunotherapy with this strategy, cancer cells are directly targeted and destroyed by the immune system. Tumour and inflammatory cells express "programmed cell death ligand one" (PD-L1), which is a membrane protein. Immunohistochemistry, a method that employs the antibodies to find certain proteins in tissue samples, is used to determine its existence. The evaluation of PD-L1 expression is thought to be a critical biomarker and it is essential for the identification of individuals who might benefit from immunotherapy.
The method employed to assess the expression of PD-L1 is immunohistochemistry which is used to visualise and quantify the levels of PD-L1 expression in tissue samples, antibodies specific to the protein.[3] Transmembrane protein PD-L1 is expressed on both immune cells which infiltrates the tumour and neoplastic cells, such as cancer cells. PD-L1 interacts with Programmed Cell Death Protein 1 (PD-1), that is typically expressed on activated T cells. The self or the cell in question inactivates the immune response against tumour cells as a result of this interaction. Recent research has shown that the PD-1/PD-L1 axis is commonly altered in a significant proportion of cases of squamous cell carcinoma of the oral cavity. This modification suggests that the tumour may have a vulnerability that might be exploited by therapeutic the  intervention.
PDL1 expression in oral squamous cell carcinoma can be used in diagnostic evaluation of patients. Therefore, this study will be performed with the aim to know the the utility of PDL1 (Programmed Cell Death Ligand One) expression as an immunohistochemical marker for assessing tumor behavior in comparison to histopathological grading and TNM staging in oral squamous cell carcinoma patients.

Methodology: Samples of 94 patients who will be to the Department of General Pathology with the specimen of oral SSC will be selected after they fulfill the requirement of the criteria. The specimens will undergo the gross examination and inspection, CAP guidelines will be used to assess the tumor’s histological grading and TNM grading will be used to assess the tumor’s staging. PDL1 immunostaining will be performed in each instance to assess protein expression. The sample will further undergo the PDL1 staining and immunohistopathology. 

Expected outcome: Significant outcomes in the PDL1 expression as immunohistochemical maker for the assessment of tumor behavior in comparison to histopathological grading & TNM staging in OSCC patients.



 
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