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CTRI Number  CTRI/2026/04/109472 [Registered on: 27/04/2026] Trial Registered Prospectively
Last Modified On: 16/03/2026
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   To study the correlation of expression of IHC marker PD-L1 with prognosis in cases of Urothelial Carcinoma of Urinary Bladder in a tertiary care hospital 
Scientific Title of Study   Study of correlation of PD-L1 expression with prognosis in Urothelial Carcinoma of Urinary Bladder: A Hospital Based Cross-Sectional 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  Najeeb Ahmed Memon 
Designation  Junior Resident 
Affiliation  KAHERs JNMC, Belagavi 
Address  Dept of Pathology, First Floor, KAHERs JNMC, Belagavi

Nashik
MAHARASHTRA
590010
India 
Phone  9823696433  
Fax    
Email  drnajeebmemon10@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Vijayalaxmi M Dhorigol 
Designation  Professor & Head of Dept 
Affiliation  KAHERs JNMC, Belagavi 
Address  Dept of Pathology, First Floor, KAHERs JNMC, Belagavi

Belgaum
KARNATAKA
590010
India 
Phone  9964318734  
Fax    
Email  vdhorigol@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Najeeb Ahmed Memon 
Designation  Junior Resident 
Affiliation  KAHERs JNMC, Belagavi 
Address  Dept of Pathology, First Floor, KAHERs JNMC, Belagavi

Nashik
MAHARASHTRA
590010
India 
Phone  9823696433  
Fax    
Email  drnajeebmemon10@gmail.com  
 
Source of Monetary or Material Support  
KAHERs JNMC, Nehru Nagar, Belagavi - 590010 (Karnataka), India 
 
Primary Sponsor  
Name  Najeeb Ahmed Memon 
Address  Dept of Pathology, First Floor, KAHERs JNMC, Belagavi - 590010 (Karnataka), India 
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 Najeeb Memon  KLEs Dr Prabhakar Kore Hospital and Medical Research Centre  Dept of Pathology, Nehru Nagar, Belagavi - 590010 (Karnataka)
Belgaum
KARNATAKA 
9823696433

drmajeebmemon10@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
JNMC INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N33||Bladder disorders in diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  85.00 Year(s)
Gender  Both 
Details  All the histopathologically diagnosed cases of UC of the Urinary Bladder that include:
1. Small, intermediate & large biopsies.
2. Resected specimens (Cystectomy) of Urothelial Carcinoma of the Urinary Bladder.
 
 
ExclusionCriteria 
Details  1. Benign lesions of the Urinary Bladder.
2. Metastatic lesions.
3. Improperly preserved samples.
4. Inadequate samples/specimens. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To study the correlation of PD-L1 expression with prognosis in Urothelial Carcinoma of Urinary Bladder.  Baseline 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="44"
Sample Size from India="44" 
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)   15/05/2026 
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)  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  

Programmed cell death ligand 1 (PD-L1) is an immune checkpoint inhibitor that is a transmembrane glycoprotein belonging to the B7/CD28 co-stimulatory family. By binding to the programmed death-1 (PD-1) receptor on T lymphocytes, PD-L1 downregulates immune responses by inducing T-cell apoptosis and functional exhaustion, thereby allowing tumour cells to evade immune surveillance. The PD-1/PD-L1 signalling axis plays a critical role in tumour immune escape, and therapeutic blockade of this pathway has been shown to restore antitumor immunity, leading to significant clinical benefit in several malignancies, including urothelial carcinoma.

PD-L1 expression has been associated with more aggressive clinical features, increased recurrence rate and reduced overall survival in patients with urothelial carcinoma. However, other studies have concluded that there is a positive relation between PD-L1 expression and favourable outcome of the disease.

Given the conflicting evidence regarding the prognostic role of PD-L1 in urothelial carcinoma of the urinary bladder which remains controversial, it is important to further define its prognostic relevance.

Hence, this study is being undertaken to evaluate the correlation of PD-L1 expression with prognosis in patients with urothelial carcinoma of the urinary bladder and further support the need for development of newer immune checkpoint inhibitors.

 
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