| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C40-C41||Malignant neoplasms of bone and articular cartilage, |
|
|
Intervention / Comparator Agent
|
|
|
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. |