| CTRI Number |
CTRI/2025/02/080753 [Registered on: 18/02/2025] Trial Registered Prospectively |
| Last Modified On: |
17/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To calculate costing details of treating childhood cancer patients in India |
|
Scientific Title of Study
|
Addressing the gap in health economics data to support national cancer control plans
in India using the Childhood Cancers Budgeting Rapidly to Incorporate Disadvantaged Groups for Equity (CC
BRIDGE) tool |
| Trial Acronym |
CC Bridge |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vasudeva Bhat K |
| Designation |
Professor |
| Affiliation |
Kasturba Medical College, Manipal, Manipal Academy of Higher Education |
| Address |
Department of Pediatric Oncology, Ground floor OPD No1, Women and Child Block, Kasturba Medical College, Manipal
Department of Pediatric Oncology, Ground floor OPD No1, Women and Child Block, Kasturba Medical College, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9619114703 |
| Fax |
|
| Email |
vasudev.bhat@manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vasudeva Bhat K |
| Designation |
Professor |
| Affiliation |
Kasturba Medical College, Manipal, Manipal Academy of Higher Education |
| Address |
Department of Pediatric Oncology, Ground floor OPD No1, Women and Child Block, Kasturba Medical College, Manipal
Department of Pediatric Oncology, Ground floor OPD No1, Women and Child Block, Kasturba Medical College, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9619114703 |
| Fax |
|
| Email |
vasudev.bhat@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vasudeva Bhat K |
| Designation |
Professor |
| Affiliation |
Kasturba Medical College, Manipal, Manipal Academy of Higher Education |
| Address |
Department of Pediatric Oncology, Ground floor OPD No1, Women and Child Block, Kasturba Medical College, Manipal
Department of Pediatric Oncology, Ground floor OPD No1, Women and Child Block, Kasturba Medical College, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9619114703 |
| Fax |
|
| Email |
vasudev.bhat@manipal.edu |
|
|
Source of Monetary or Material Support
|
| INPHOG
Raheja Atlantis, B 181, Sector 31, Gurugram, Haryana 122001
Phone: 098184 56444 |
|
|
Primary Sponsor
|
| Name |
Dr Vasudeva Bhat K |
| Address |
Division of Pediatric Hematology and Oncology |
| Type of Sponsor |
Other [INPHOG, Raheja Atlantis, B 181, Sector 31, Gurugram, Haryana 122001 Phone: 098184 56444] |
|
|
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 |
| Vasudeva Bhat K |
Kasturba Medical College, Manipal, Manipal Academy of Higher Education |
Division of Pediatric Hematology and Oncology
Udupi
KARNATAKA |
9619114703
vasudev.bhat@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Only demograhic data to be collected |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Government and trust hospitals will be included |
|
| ExclusionCriteria |
| Details |
Private medical colleges and for profit institutes will be excluded |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To estimate a national budget for pediatric cancer programs in India
|
at 6 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To estimate 5-year scale up scenarios and costs
2. To calculate annual cost-effectiveness of pediatric cancer treatment in India |
6 months |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
01/03/2025 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [vasudev.bhat@manipal.edu].
- For how long will this data be available start date provided 01-01-2025 and end date provided 01-01-2030?
Response (Others) -
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Childhood Cancer is a
pressing health issue in India, with survival rates at 20% for low-income and middle-income countries
(LMICs) compared to 80% for high-income countries (HICs)(Cotache-Condor et al., 2023). A recent
assessment of childhood cancer services in India revealed gaps in availability of specialised pediatric
cancer care, including essential drugs and infrastructure for radiotherapy and chemotherapy,
particularly in public hospitals (Nath et al., 2023). The inclusion of childhood cancer in national cancer
control response was identified as a key priority to improve childhood cancer outcomes in India. National
Cancer Control Plans (NCCPs) aim to reduce the cancer burden through strategic, evidence-based
approaches for cancer screening, diagnosis, treatment, research and policy (Oar et al., 2019). However,
many NCCPs lack specific financial data and planning, and do not address childhood cancers (Romero
et al., 2018; Weaver et al., 2015). Childhood cancers require distinct decision making and inclusion in
NCCPs can help prioritize spending for childhood cancers in national budgets and guide effective
treatment and advocacy efforts (Weaver et al., 2017). Currently, there is a lack of specific childhood
cancer policy or programme components in India and limited information as to the quality of childhood
cancer care (Nath et al., 2023). This study aims to estimate a national budget for childhood cancer
programs in India to inform the NCCP and improve childhood cancer outcomes. Additionally, this study
aims to conduct a cost-effectiveness analysis for childhood cancer care in India, better informing policy
and planning efforts. |