| CTRI Number |
CTRI/2026/04/107933 [Registered on: 09/04/2026] Trial Registered Prospectively |
| Last Modified On: |
08/04/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Retrospective |
| Study Design |
Other |
|
Public Title of Study
|
A Study of How Different Types of Bladder Cancer Are Managed and How Patients Do After Treatment. |
|
Scientific Title of Study
|
A Multi-institutional Review of Management and Outcomes of Subtypes of Urothelial
Carcinoma of Bladder. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr GAGAN PRAKASH |
| Designation |
Professor, Uro - Surgical Oncology |
| Affiliation |
Tata Memorial Hospital |
| Address |
1212, 12th Floor,Homi Bhabha Block, Tata Memorial Hospital, Parel, Mumbai 400012
Mumbai
MAHARASHTRA
400012
India
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9833722711 |
| Fax |
|
| Email |
gagan2311@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr GAGAN PRAKASH |
| Designation |
Professor, Uro - Surgical Oncology |
| Affiliation |
Tata Memorial Hospital |
| Address |
1212, 12th Floor,Homi Bhabha Block, Tata Memorial Hospital, Parel, Mumbai 400012
Mumbai
MAHARASHTRA
400012
India
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9833722711 |
| Fax |
|
| Email |
gagan2311@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr GAGAN PRAKASH |
| Designation |
Professor, Uro - Surgical Oncology |
| Affiliation |
Tata Memorial Hospital |
| Address |
1212, 12th Floor,Homi Bhabha Block, Tata Memorial Hospital, Parel, Mumbai 400012
Mumbai
MAHARASHTRA
400012
India
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9833722711 |
| Fax |
|
| Email |
gagan2311@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Tata Memorial Hospital |
| Address |
Dr Ernst Borges Road Parel Mumbai 400012
|
| Type of Sponsor |
Research institution and hospital |
|
|
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 GAGAN PRAKASH |
Tata Memorial Hospital |
Room No. 222, 2nd Floor,
Homi Bhabha Block,
Tata Memorial Hospital, Dr. E. Borges Marg,
Parel (E), Mumbai:- 400012
Mumbai
MAHARASHTRA |
9833722711
gagan2311@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C679||Malignant neoplasm of bladder, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients treated at TMC, Mumbai after 1/1/2016
Age is more than 18
Urothelial carcinoma of bladder with one or more of the following subtype(s):
Micropapillary
Squamous differentiation
Glandular differentiation
Sarcomatoid
Small cell/ Neuroendocrine
Plasmacytoid
Nested
Tubular and microcystic
Lymphoepithelioma-like
Giant cell
Clear cell
Poorly differentiated |
|
| ExclusionCriteria |
| Details |
Patients with pure urothelial carcinoma, lymphoma, and other rare pathology will be excluded.
Patients with presence of metastasis to the bladder from other primary organs will be excluded.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Overall survival (OS) and disease-free survival (DFS) in patients with subtypes of urothelial carcinoma of the bladder, analysed according to histological subtype and treatment modality. |
Overall survival and disease-free survival will be assessed retrospectively from the date of diagnosis or definitive treatment (TURBT or cystectomy) until the date of last follow-up or death, over the entire follow-up period (January 2016 to December 2024). |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Treatment response, subtype-wise & treatment-based oncological outcomes, recurrence patterns, & pathological prognostic factors influencing survival in patients with subtypes of urothelial carcinoma of the bladder. |
Baseline (at diagnosis), & during follow-up at 1 year, 3 years, & 5 years from definitive treatment (TURBT or cystectomy), or until recurrence, last follow-up, or death, whichever occurs first. |
|
|
Target Sample Size
|
Total Sample Size="500"
Sample Size from India="500"
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)
|
04/05/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
04/05/2026 |
| 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 retrospective, observational study evaluates the management and oncological outcomes of adult patients with subtype urothelial carcinoma of the bladder treated at Tata Memorial Centre, Mumbai after 1 January 2016. Patients with histologically confirmed variant subtypes of urothelial carcinoma will be included. Clinical, pathological, treatment, and outcome data will be collected from institutional electronic medical records. Outcomes assessed include overall survival, disease-free survival, and recurrence patterns. Subgroup analyses will evaluate outcomes by histological subtype, treatment modality, and use of neoadjuvant chemotherapy. This study aims to enhance understanding of disease behavior and outcomes in subtype urothelial carcinoma of the bladder and support evidence-based management strategies. |