| 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
|
|
|
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.
|