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CTRI Number  CTRI/2022/06/043526 [Registered on: 27/06/2022] Trial Registered Prospectively
Last Modified On: 31/01/2023
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Single Arm Study 
Public Title of Study   Establishing a registry to collect data on childhood cancer in Chennai, India. 
Scientific Title of Study   Establishing the First Dedicated Population-Based Childhood Cancer Registry (PBCCR) And Network Of Hospital-Based Childhood Cancer Registries (HBCCRs) in India. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Venkatraman Radhakrishnan 
Designation  Professor Medical Oncology 
Affiliation  Cancer Institute 
Address  Cancer Institute, Canal Bank Road, Adyar, Chennai

Chennai
TAMIL NADU
600020
India 
Phone  9498082771  
Fax    
Email  venkymd@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Venkatraman Radhakrishnan 
Designation  Professor Medical Oncology 
Affiliation  Cancer Institute 
Address  Cancer Institute, Canal Bank Road, Adyar, Chennai


TAMIL NADU
600020
India 
Phone  9498082771  
Fax    
Email  venkymd@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Venkatraman Radhakrishnan 
Designation  Professor Medical Oncology 
Affiliation  Cancer Institute 
Address  Cancer Institute, Canal Bank Road, Adyar, Chennai


TAMIL NADU
600020
India 
Phone  9498082771  
Fax    
Email  venkymd@gmail.com  
 
Source of Monetary or Material Support  
Cancer Institute, India 
Conquer Cancer Foundation, USA 
St Jude Childrens Hospital, USA 
 
Primary Sponsor  
Name  Cancer Institute 
Address  Canal Bank Road, Adyar, Chennai, India, 600020 
Type of Sponsor  Research institution and hospital 
 
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 Venkatraman Radhakrishnan  Cancer Institute  Madras Metropolitan Tumor Registry, Department of Cancer Registry, Epidemiology and Biostatistics, Canal Bank Road, Adyar, Chennai
Chennai
TAMIL NADU 
9498082771

venkymd@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Cancer Institute  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C00-D49||Neoplasms,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  0.00 Year(s)
Age To  19.00 Year(s)
Gender  Both 
Details  All cancers and non-malignant brain tumors in children aged less than or equal to 19 years and residents of the Chennai metropolitan region in the Tamil Nadu state of India will be eligible for registration in the PBCCR. 
 
ExclusionCriteria 
Details  1. Patients with cancer above 19 years.
2. Patients whose residence is outside Chennai metropolitan region. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. To map all the potential data sources that provide patient data to the Chennai PBCCR and evaluate the completeness of data regarding patient identity, disease information, and follow-up.
2. To map the existing HBCCRs functioning in Chennai 
5 years  
 
Secondary Outcome  
Outcome  TimePoints 
1. To evaluate the quality of data from each of the identified sources.
2. To design a case record form (CRF) to standardize data capture from all sources.
3. To identify barriers and enablers for the implementation of PBCCR in Chennai through an implementation study.
4. To evaluate the existing data on childhood cancer in Chennai to identify gaps and gain insight needed for designing an efficient registration system.
5. To define the aims, role, output, and impact of the PBCCR in Chennai.
6. To identify the relevant stakeholders willing and able to support the development of the registry and engage them, for example, through membership of a registry committee.
7. To develop a 5-year plan of the PBCCR development, including the performance and evaluation indicators.
8. To develop a manual anchoring the PBCCR operations.
 
5 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)   01/07/2022 
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="5"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [venkymd@gmail.com].

  6. For how long will this data be available start date provided 01-07-2023 and end date provided 01-06-2030?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  
An important component of improving the survival of children with cancer in low and middle-income countries (LMICs) and achieving the targets set by the World Health Organization (WHO), Global Initiative for Childhood Cancer (GICC), is to capture the incidence and outcome of children with cancer. This objective can be best served through a dedicated population-based childhood cancer registry (PBCCR). A PBCCR tries to capture data on all newly diagnosed cancer cases in a geographical region from multiple and heterogeneous sources, including hospitals, community, and government vital statistics records. A PBCCR provides information on cancer incidence and patterns in the population being served. To date, there is a lack of high-resolution data to perform an in-depth analysis of variation in childhood cancer incidence and survival in India. General cancer registries do not capture detailed information on pediatric cancers; therefore, their data is inadequate to understand the epidemiology and outcomes of pediatric cancers. We, therefore, plan to establish the first dedicated pediatric PBCCR in Chennai, India. If successful, the Chennai PBCCR can serve as an example for establishing similar registries in India and other LMICs. Childhood cancers are rare, and most children with cancer are treated at few tertiary cancer hospitals in a region or country. Hospital-based childhood cancer registries (HBCCRs) collect more detailed data on socio-demographic features, staging, and treatment than general cancer registries. Therefore, HBCCRs are important contributors to the development of PBCCR. The success of a PBCCR is dependent on the quality of the data obtained from the HBCCRs. The project aims to strengthen the existing HBCCRs in Chennai metropolitan region by forming a network and ensuring that data recorded is comparable, valid, timely, and complete. We would also identify the enablers and barriers for establishing and running a PBCCR and network of HBCCRs through an implementation science perspective. The observations in the implementation study will help understand the challenges in establishing a PBCCR and will serve as a guide for establishing similar registries in India and other countries. The PBCCR will be developed using best practice, disseminated notably through the Targeting Childhood Cancer through the Global Initiative for Cancer Registry Development (ChildGICR). The PBCCR will be established at the Cancer Institute (W.I.A), Chennai, India. Cancer Institute is a 67-year-old, 500 bed, non-profit, charitable, teaching, and leading cancer center in India. The hospital-based and population-based registry was first established at the Institute in 1954 and 1981, respectively. The Tamilnadu state cancer registry project was initiated at the Institute in 2016. Therefore, Cancer Institute(W.I.A) has the necessary experience and resources to spearhead the first dedicated PBCCR in India. The project has received ethics committee approval.
 
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