| 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
|
|
|
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
|
|
|
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. |