| 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
|
|
|
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
|
|
|
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
- 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
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [venkymd@gmail.com].
- 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.
- 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. |