| CTRI Number |
CTRI/2024/06/068713 [Registered on: 11/06/2024] Trial Registered Prospectively |
| Last Modified On: |
07/06/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
non-interventional |
| Study Design |
Other |
|
Public Title of Study
|
Real world study of Bladder Cancer patients in India |
|
Scientific Title of Study
|
Real-World Treatment Patterns and Clinical Outcomes Among Patients with Urothelial Carcinoma (UC) in India |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| B8011015 version 1 dated 22 August 2023 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Antara Chaudhri |
| Designation |
Medical Adviosor, Oncology |
| Affiliation |
Pfizer Products India Private Limited |
| Address |
The Capital, 1802 / 1901, Plot No. C-70,
G Block, Bandra Kurla Complex,
Bandra (E), Mumbai
Mumbai
MAHARASHTRA
400051
India |
| Phone |
|
| Fax |
02266932000 |
| Email |
antara.chaudhri@pfizer.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Antara Chaudhri |
| Designation |
Medical Adviosor, Oncology |
| Affiliation |
Pfizer Products India Private Limited |
| Address |
The Capital, 1802 / 1901, Plot No. C-70,
G Block, Bandra Kurla Complex,
Bandra (E), Mumbai
Mumbai
MAHARASHTRA
400051
India |
| Phone |
02266932000 |
| Fax |
|
| Email |
antara.chaudhri@pfizer.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Antara Chaudhri |
| Designation |
Medical Adviosor, Oncology |
| Affiliation |
Pfizer Products India Private Limited |
| Address |
The Capital, 1802 / 1901, Plot No. C-70,
G Block, Bandra Kurla Complex,
Bandra (E), Mumbai
MAHARASHTRA
400051
India |
| Phone |
02266932000 |
| Fax |
|
| Email |
antara.chaudhri@pfizer.com |
|
|
Source of Monetary or Material Support
|
| Pfizer Products India Private Limited, Mumbai |
|
|
Primary Sponsor
|
| Name |
Pfizer Products India Private Limited |
| Address |
The Capital, 1802 / 1901, Plot No. C-70,G Block, Bandra Kurla Complex,
Bandra (E), Mumbai – 400 05 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 8 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vineet Talwar |
Rajiv Gandhi Cancer Institute and Research Centre |
Rajiv Gandhi Cancer Institute and Research Centre, Sector-5 , Rohini, New Delhi – 110085
New Delhi
DELHI |
9810241512
drvineettalwar@yahoo.com |
| Dr Atul Batra |
AIIMS New Delhi |
Dr. B.R Ambedkar Institute Rotary Cancer Hospital, Department of Medical Oncology, AIIMS New Delhi- 110029,
New Delhi
DELHI |
9013078407
batraatul85@gmail.com |
| Dr Ashish Singh |
CMC Vellore |
Christian Medical College, Vellore- 632004,
Vellore
TAMIL NADU |
9445659460
ashishsingh@cmcvellore.ac.in |
| Dr Ashish Joshi |
Mumbai Oncocare Centre |
Mumbai Oncocare Centre (Unit of Cellcure Cancer Centre Pvt Ltd, 2nd Floor, Majithia Apartments, God’s Gift Premises Co-op. society Ltd, S V Road, Irla, Vile Parle (West), Mumbai, 400056
Mumbai
MAHARASHTRA |
9445659460
ashjoshi44@mocindia.co.in |
| Dr Anand Pathak |
National Cancer Institute |
National Cancer Institute, Khassara no 25, Outer Hinga ring Road, Mouza Jamtha, Nagpur- 441108
Nagpur
MAHARASHTRA |
9823038498
ethics@ncinagpur.in |
| Dr Arnab Bhattacharjee |
TATA MEDICAL CENTRE - Kolkata |
Tata Medical Center, 14 Major Arterial Road (EW), Newtown, Rajarhat, Kolkata – 700160
Kolkata
WEST BENGAL |
7980672007
arnab1572@gmail.com |
| Dr Akhil Kapoor |
Tata memorial Centre, Varanasi |
Department of Medical oncology at Tata memorial Centre (Homi Bhabha Hospital & Mahamana Pandit Madan Mohan Maviya Cancer Centre), Varanasi, 221005
Varanasi
UTTAR PRADESH |
9950482121
kapoorakhil1987@gmail.com |
| Dr Amit Joshi |
Tata Memorial Hospital |
Tata memorial Hospital, Dept of Medical oncology
Mumbai
MAHARASHTRA |
9769331525
dramitjoshi74@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 8 |
| Name of Committee |
Approval Status |
| Ethics Committee, All India Institute of Medical Sciences, Room No 102, 1st Floor, Old O.T . Block, Ansari nagar, New Delhi, 110029 |
Submittted/Under Review |
| IEC, MPMMCC and HBCH Varanasi Mahamana Pandit Madan Mohan Malaviya Cancer Centre Sundar Bagiya, Near Nariya Gate Banaras Hindu University Campus Varanasi Varanasi Uttar Pradesh - 221005 India |
Submittted/Under Review |
| Institutional Ethics Committee, National Cancer Institute, Nagpur- 441108 |
Submittted/Under Review |
| INSTITUTIONAL REVIEW BOARD CHRISTIAN MEDICAL COLLEGE THORAPADI POST BAGAYAM VELLORE Vellore Tamil Nadu - 632012 India |
Submittted/Under Review |
| INSTITUTIONAL REVIEW BOARD TATA MEDICAL CENTER 14 MAJOR ARTERIAL ROAD EW RAJARHAT NEW TOWN Kolkata West Bengal - 700160 India |
Submittted/Under Review |
| Institutional Review Board, Rajiv Gandhi Cancer Institute & Research Centre, sector 5 , Rohini, Delhi - 110085, India |
Approved |
| Mumbai Oncocare Centre IEC Cellcure Cancer Centre Private Limited Majithira Apartment, God Gift Premises SV Road, Ville Parle West, Mumbai Mumbai Mumbai Suburban Maharashtra - 400056 India |
Approved |
| The Chairman, TMH, Institutional Ethics Committee-I, Tata memorial Hospital, Dr.E Borges Road, Parel, Mumbai, Mumbai city, Maharasthtra- 400012 India |
Submittted/Under Review |
|
|
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 |
| Comparator Agent |
none |
none |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
All patients of high risk NMIBC who both initiated treatment and/or diagnosed Jan 2023 onwards.
All patients of metastatic urothelial carcinoma who initiated treatment and/or diagnosed Jan 2023 onwards.
Aged at least 18 years upon diagnosis. |
|
| ExclusionCriteria |
| Details |
Previously enrolled in an interventional trial related to High-risk NMIBC or mUC |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Overall Survival (OS) outcomes of patients with High-risk NMIBC and mUC treated at tertiary care institutions in India. (The percentage of people in the study who are still alive for a certain period of time after they were diagnosed with or started treatment for cancer). |
18 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To understand the baseline characteristics of the
patient/disease status
To understand the treatments received and reasons for
change
To understand the laboratory investigations if
available
To understand the frequency and severity of adverse
events
|
18 Months |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
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)
|
20/06/2024 |
| 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="1"
Months="5"
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
|
Notification for
the conduct of Non- interventional study- ‘Real-World
Treatment Patterns and Clinical outcomes among Patients with Urothelial
Carcinoma (UC) in India’, Protocol Number B8011015, Version 1.0
Dated 22-Aug-2023. |