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CTRI Number  CTRI/2023/05/053100 [Registered on: 24/05/2023] Trial Registered Prospectively
Last Modified On: 12/07/2023
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Multicentric study on outcome of treatment of osteosarcoma in India, conducted by Indian Musculo Skeletal Oncology Society  
Scientific Title of Study   Evaluation of clinico-pathological characteristics, prognostic factors and treatment outcomes in patients with osteosarcoma in children and adults treated in India 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
IMSOS OS-01 Version 1.0 December 2022   Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)  
Name  Akshay Tiwari 
Designation  Director, Musculoskeletal Oncology 
Affiliation  National Accreditation Board for Hospitals & Healthcare Providers , Joint Commission International 
Address  Max Institute of Cancer Care East Block (A unit of Devki Devi Foundation) Max Super Speciality Hospital Saket New Delhi 2 Press Enclave Road Saket 110017 New Delhi India
Max Super Speciality Hospital Saket New Delhi 2 Press Enclave Road Saket 110017 New Delhi India
South
DELHI
110017
India 
Phone  9818002611  
Fax  911126510050  
Email  akshay_t_2000@yaho.com  
 
Details of Contact Person
Scientific Query

Modification(s)  
Name  Akshay Tiwari 
Designation  Director, Musculoskeletal Oncology 
Affiliation  National Accreditation Board for Hospitals & Healthcare Providers, Joint Commission International 
Address  Max Institute of Cancer Care, East Block- A unit of Devki Devi Foundation, Max Super Speciality Hospital, Saket, New Delhi
Max Super Speciality Hospital Saket New Delhi 2 Press Enclave Road Saket 110017 New Delhi India
South
DELHI
110017
India 
Phone  9818002611  
Fax  911126510050  
Email  akshay_t_2000@yaho.com  
 
Details of Contact Person
Public Query

Modification(s)  
Name  Akshay Tiwari 
Designation  Director, Musculoskeletal Oncology 
Affiliation  National Accreditation Board for Hospitals & Healthcare Providers , Joint Commission International 
Address  Max Institute of Cancer Care, East Block- A unit of Devki Devi Foundation, Max Super Speciality Hospital, Saket, New Delhi
Max Super Speciality Hospital Saket New Delhi 2 Press Enclave Road Saket 110017 New Delhi India
South
DELHI
110017
India 
Phone  9818002611  
Fax  911126510050  
Email  akshay_t_2000@yaho.com  
 
Source of Monetary or Material Support  
Indian Musculo Skeletal Oncology Society (IMSOS) 
 
Primary Sponsor  
Name  Indian Musculo Skeletal Oncology Society (IMSOS) 
Address  Sparsh Orthopaedic Oncology Clinic 9th Floor, Medicare Building, Behind M.J. Library, Ellisbridge, Ahmedabad – 380006, 
Type of Sponsor  Other [IMSOS is a society of professionals involved in management of musculoskeletal tumors.] 
 
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 
Akshay Tiwari  Max Institute of Cancer Care, East Block- Devki Devi Foundation   First Floor OPD, Room number 05
South
DELHI 
09818002611

akshay_t_2000@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Devki Devi Foundation   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C40-C41||Malignant neoplasms of bone and articular cartilage,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  0.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  All patients with proven tissue diagnosis of osteosarcoma diagnosed on January 2001 or later, and treated in India for the same
 
 
ExclusionCriteria 
Details  Patients without histopathologically confirmed diagnosis of osteosarcoma 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Overall and event free survival will be assessed as primary outcome over the time period of five years.  Five years 
 
Secondary Outcome  
Outcome  TimePoints 
Relationship of prognostic variables with overall and event free survival will be assessed as secondary outcome over the period of five years.  Five years 
 
Target Sample Size   Total Sample Size="1000"
Sample Size from India="1000" 
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)   01/07/2023 
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   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Osteosarcoma is the most common bone sarcoma, most commonly affecting children and adolescents. The management of osteosarcoma has evolved to a point where the 5 years survival rates are above 70 %. Though these advancements are reflected in the data from some Indian studies as well (even if the outcomes still lag behind those of international studies), these studies are largely limited only to some centres in major Indian cities.

Across the globe, apart from single centre studies, the outcome of osteosarcoma has been studied in many prospective and retrospective multicentric studies as well. The contribution of these multicentric studies has been invaluable in understanding the outcome of osteosarcoma management and, even more importantly, making of policies and guidelines and allocation of resources. This becomes even more important in the Indian context, to be able the gauge uniformity and patterns of treatment, gaps in promptness of referral and initiation of treatment, availability (or lack) of specialized orthopaedic oncology units across centres, protocols of chemotherapy being followed across various centres and abandonment of treatment. Such a study would also provide more insight into, and indigenous solutions to, the problems faced by LMIC countries. 

This retrospective observational multicentric study, under the aegis of IMSOS, aims to analyse the demographics, characteristics and oncological outcomes of management of osteosarcoma in Indian patients treated in centres across India, diagnosed from 2001till date. The participating centres will be invited to fill up the details in the attached Google survey form. All patients will then be analysed for demographic, clinicoradiological and pathological details, management details and oncological outcomes. The aim of this study will be to study demographic and treatment patterns of osteosarcoma in India and attempt to correlate these with oncological outcomes of these patients.

 
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