| CTRI Number |
CTRI/2024/10/075688 [Registered on: 23/10/2024] Trial Registered Prospectively |
| Last Modified On: |
06/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
observational |
| Study Design |
Other |
|
Public Title of Study
|
A study done on children with Low risk and intermediate risk neuroblastoma using a uniform protocol |
|
Scientific Title of Study
|
India Cooperative Neuroblastoma Study: Non-high risk |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| InPHOG-NB-23-02 (ICON- NHR-23) |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrYamini Krishnan |
| Designation |
HOD and Senior Consultant Paediatric-hematology, oncology and bone marrow transplantation |
| Affiliation |
MVR Cancer centre and Research Institute. |
| Address |
Room number 34
MVR Cancer centre and Research Institute.CP13/516B.C, Vellalasseri, REC via, Poolacode,Kozhikode , Kerala 673601
Kozhikode
KERALA
673601
India |
| Phone |
9446981696 |
| Fax |
|
| Email |
dryamini@mvrccri.co |
|
Details of Contact Person
Scientific Query
|
| Name |
DrYamini Krishnan |
| Designation |
HOD and Senior Consultant Paediatric-hematology, oncology and bone marrow transplantation |
| Affiliation |
MVR Cancer centre and Research Institute. |
| Address |
room number 34
MVR Cancer centre and Research Institute.CP13/516B.C, Vellalasseri, REC via, Poolacode,Kozhikode , Kerala 673601
Kozhikode
KERALA
673601
India |
| Phone |
9446981696 |
| Fax |
|
| Email |
dryamini@mvrccri.co |
|
Details of Contact Person
Public Query
|
| Name |
DrYamini Krishnan |
| Designation |
HOD and Senior Consultant Paediatric-hematology, oncology and bone marrow transplantation |
| Affiliation |
MVR Cancer centre and Research Institute. |
| Address |
MVR Cancer centre and Research Institute.CP13/516B.C, Vellalasseri, REC via, Poolacode,Kozhikode , Kerala 673601
Kozhikode
KERALA
673601
India |
| Phone |
9446981696 |
| Fax |
|
| Email |
dryamini@mvrccri.co |
|
|
Source of Monetary or Material Support
|
| Department of Paediatric Hematology Oncology and Bone marrow transplantation
Room Number 34
MVR Cancer Centre and Research Institute
CP13/516 B.C
Vellalassery PO
NIIT (via)
Chuloor
Kozhikode
KeralaÂ
Pin 673601 |
|
|
Primary Sponsor
|
| Name |
Indian Pediatric Hematology Oncology Group INPHOG |
| Address |
Raheja Atlantis, B 181, Sector 31, Gurugram, Haryana 122001 |
| Type of Sponsor |
Other [Research foundation] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 6 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrRaghwesh Ranjan |
Homi Bhabha Cancer Hospital |
Old Loco Colony, Shivpurwa, Varanasi, Uttar Pradesh 221010
Varanasi
UTTAR PRADESH |
9660417130
raghavranjan007@gmail.com |
| DrYamini Krishnan |
MVR Cancer centre and Research Institute. |
HOD and senior consultant pediatric hematology , oncology and bone marrow transplantation, Room no: 34,department : pediatric hematology , oncology and bone marrow transplantation , Vellalassery - kalanthod road, Poolacode, Kerala 673601
Kozhikode
KERALA |
9446981696
dryamini@mvrccri.co |
| Dr Prasanth VR |
Regional Cancer Centre |
Medical College Kumarapuram Rd, Medical College Campus, Chalakkuzhi, Thiruvananthapuram, Kerala 695011
Thiruvananthapuram
KERALA |
8281742466
paedia2010@gmail.com |
| DrFaisal Guru |
Sher-I-Kashmir institute of medical science |
KIMS Main Rd, Soura, Srinagar, Jammu and Kashmir 190011
Srinagar
JAMMU & KASHMIR |
9717017022
faisal_guru@yahoo.com |
| DrManas Kalra |
Sir Ganga Ram Hospital |
Sir Ganga Ram Hospital Marg, Old Rajinder Nagar, Rajinder Nagar, New Delhi, Delhi, 110060
New Delhi
DELHI |
9958255228
manaskalra27@gmail.com |
| DrDeepaHTrivedi |
Vedanta Hospital |
1st Floor,Near Vedanta Institute of Medical Sciences, Commerce Six Rd, Swastik Society, Navrangpura, Ahmedabad, Gujarat 380009
Ahmadabad
GUJARAT |
9924225911
deepahiren@yahoo.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 19 |
| Name of Committee |
Approval Status |
| APOLLO CHENNAI INSTITUTIONAL ETHICS COMMITTEE |
Approved |
| APOLLO NEW DELHI INSTITUTIONA ETHICS COMMITTEE |
Approved |
| B J WADIA INSTITUTIONAL ETHICS COMMITTEE |
Approved |
| BASAVATARAKAM INDOAMERICAN CANCER HOSPITAL & RESEARCH INSTITUTE Promoted by Smt.Nandamuri Basavataraka Ramarao |
Approved |
| BHARATI VIDYAPEETH INSTTUTIONAL ETICS COMMITTEE |
Approved |
| DAYANAND MEDICAL COLLEGE LUDHIANA |
Approved |
| ETHICS COMMITTEE OF KANCHI KAMAKOTI CHILDS TRUST HOSPITAL |
Approved |
| ETHICS COMMITTEE, SIR GANGA RAM HOSPITAL |
Approved |
| IEC-SKIMS |
Approved |
| INSTITUTIONAL ETHICS COMMITTEE DEVKI DEVI FOUNDATION MAX |
Approved |
| INSTITUTIONAL HUMAN ETHICS COMMITTE AIIMS BHOPAL |
Approved |
| JIPMER INSTITUTIONAL ETHICS COMMITTEE FOR OBSERVATIONAL STUDIES |
Approved |
| KASTURBA INSTITUTIONAL ETHICS COMMITTEE |
Approved |
| KIDWAI MEDICAL ETHICS COMMITTEE |
Approved |
| MVR cancer centre and research institute |
Approved |
| SRI RAMACHANDRA INSTITUTIONAL ETHICS COMMITTEE |
Approved |
| ST.JOHNS BANGLORE |
Approved |
| Tata Medical Center-Institutional Review Board |
Approved |
| TATA MEMORIAL HOSPITAL INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C749||Malignant neoplasm of unspecifiedpart of adrenal gland, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
| Intervention |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
1. All newly diagnosed patients with confirmed low-risk and intermittent-risk neuroblastoma, seen at participating institutions are eligible for this study.
2. All patients and/or their parents or legal guardians must sign a written informed consent with age-appropriate child assent.
|
|
| ExclusionCriteria |
| Details |
1 Patients who are high risk i.e. they have tumors with MYCN amplification or have metastatic disease and are over 12 months of age or are 12-18 months of age with documented SCA, are excluded from this protocol.
2 Patients with ganglioneuroma are excluded.
3 Absent informed consent and age-appropriate assent
4 In the case of children who have received chemotherapy for LTS there is no documentation of the chemotherapy received or the child has received more than 2 cycles of chemotherapy.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 3 year overall survival outcome for children with low risk and intermediate risk neuroblastoma |
3year survival |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To implement a uniform risk stratification
2.To determine the progression free survival
3. To establish an INPHOG neuroblastoma surgical tumour board |
3 years |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
30/10/2024 |
| 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="3"
Months="0"
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 - NO
|
|
Brief Summary
|
Neuroblastoma(NB) is the commonest extracranial solid tumour in children. treatment in India poses challenges because of the relatively low number of patients an individual oncologist might see with subsequent variations in treatment. Recently, Kanwar and colleagues presented the InPHOG 01 neuroblastoma registration study resultsfrom India . 322 children were diagnosed with NB from 2016 to 2021 in 14 centres across India. The staging included PET-CT (177/322), MYCN (233/322), and pathology (INPC). Histopathology was favorable and unfavorable in 107 and 187 children respectively. INRG staging demonstrated that almost half of the patients were classified as L1 (n=41). L2 (n=95) and MS (n=15), with M constituting the remainder. A total of 190 patients underwent biopsy, 50 surgery, and 228 received chemotherapy, with 3-year event free survival (EFS) for L1=84.8%, L2=66.4%, and MS= 46.7%. It is with this background that the InPHOG NB 23-02 study is being planned.Primary objective is to utilize a uniform staging system, that includes age, stage, pathology and limited genomic testing, to accurately risk stratify patients with neuroblastoma in India, and to document >80% 3-year overall survival outcomes for children with low risk and intermediate Risk neuroblastoma..This study is open to newly diagnosed neuroblastoma patients at InPHOG partner institutions, with low or intermediate risk disease determined by age, stage, and MYCN status. Infants under 6 months with adrenal mass < 5cm in diameter and no spread evidence are eligible. Patients with prior emergent chemotherapy due to life-threatening symptoms are eligible, but documentation is required. Written consent and institutional ethics must be met.This protocol excludes high-risk patients with MYCN amplification, metastatic disease, over 12 months of age, or those with ganglioneuroma, and children with LTS chemotherapy without documented or multiple cycles. Children will be given a uniform protocol at all centres and followed up for overall survival. |