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CTRI Number  CTRI/2021/01/030770 [Registered on: 27/01/2021] Trial Registered Prospectively
Last Modified On: 28/01/2021
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Other 
Public Title of Study   Patterns of care and survival of renal tumour in children in India 
Scientific Title of Study   Patterns of care and survival of renal tumours in children in India-A retrospective multi-centric study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sirisha rani Siddaiahgari 
Designation  Head of the department 
Affiliation  Rainbow Childrens hospital 
Address  Room no 10 Department of Pediatric hematology and Oncology. Rainbow Childrens hospital Road no 2 Banjara hills Beside LV Prasad eye hospital Ph no 040 44665555 ext 1010

Hyderabad
TELANGANA
500034
India 
Phone  9959985558  
Fax    
Email  lokisiri@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Sirisha rani Siddaiahgari 
Designation  Head of the department 
Affiliation  Rainbow Childrens hospital 
Address  Room no 10 Department of Pediatric Hematology and Oncology Rainbow Childrens hospital Road no 2 Banjara hills Beside LV Prasad eye hospital Ph no 040 44665555 ext 1010

Hyderabad
TELANGANA
500034
India 
Phone  9959985558  
Fax    
Email  lokisiri@gmail.com  
 
Details of Contact Person
Public Query  
Name  Sirisha rani Siddaiahgari 
Designation  Head of the department 
Affiliation  Rainbow Childrens hospital 
Address  Room no 10 Department of pediatric hematology and Oncology Rainbow childrens hospital Road no 2 Banjara hills Beside LV Prasad eye hospital Ph no 040 44665555 ext 1010

Hyderabad
TELANGANA
500034
India 
Phone  9959985558  
Fax    
Email  lokisiri@gmail.com  
 
Source of Monetary or Material Support  
nil 
 
Primary Sponsor  
Name  Rainbow Childrens Hospital 
Address  Road No 2, banjara hills, Hyderabad Telangana 
Type of Sponsor  Private hospital/clinic 
 
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 Sirisha Rani S  Rainbow Childrens hospital  Room no 10 Department of Pediatric Hematology and Oncology Road no 2 Banjara hills Beside LV Prasad eye hospital
Hyderabad
TELANGANA 		 9959985558

lokisiri@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Instituional Ethics Committee Devki Devi Foundation  Approved 
Rainbow hospital Institutional ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C649||Malignant neoplasm of unspecifiedkidney, except renal pelvis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  nil  nil 
 
Inclusion Criteria  
Age From  0.00 Day(s)
Age To  18.00 Year(s)
Gender  Both 
Details  • All children less than 18 years of age diagnosed with primary renal tumour.
• Patient who received partial treatment in the participating centre would still be eligible as long as adequate details of treatment done outside participating centre is available and follow-up was done
 
 
ExclusionCriteria 
Details  • Relapsed cases
• Patient where entire treatment details are not available
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. To describe the 5-year EFS and OS of children 18 year with renal tumours in India and factors associated with survival  1. To describe the 5-year EFS and OS of children 18 year with renal tumours in India and factors associated with survival 
 
Secondary Outcome  
Outcome  TimePoints 
1. To describe the patterns of care of children 18 year with WT in India
2. To identify patterns of failure including mortality, progression/relapse and abandonment of treatment in children 18 year with WT in India
3. To describe patterns of care and survival of children 18 year with non-Wilms renal tumours in India.
 		 5yr 
 
Target Sample Size   Total Sample Size="250"
Sample Size from India="250" 
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)   30/01/2021 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Wilms tumour is 2nd most common extracranial solid tumour and has excellent outcomes with combined modality of treatment. Two treatment approaches are being used worldwide. The Children’s Oncology Group (COG) in North America does upfront surgery in most patients. The approach of the SIOP Renal tumour Study group is to give preoperative chemotherapy. In high income countries, survival of both strategies is the same.

In India there is a paucity of data on outcomes with different centres following different protocols. Hence this study has been planned to retrospectively analyse the epidemiology, clinical presentation, patterns of care and outcomes of children with Wilms tumour in India. This information will set the baseline in India and guide future studies.

 
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