| CTRI Number |
CTRI/2025/11/096796 [Registered on: 03/11/2025] Trial Registered Prospectively |
| Last Modified On: |
31/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Longitudinal study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study on determining utility of an internet based application used for dose adjustment in the chemotherapy medicines prescribed to the children diagnosed with acute lymphoblastic leukemia (a type of blood cancer). |
|
Scientific Title of Study
|
Web based mobile application for titrating maintenance therapy in children with acute lymphoblastic leukemia |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Chetan Dhamne |
| Designation |
Professor, Medical Oncology-Pediatrics |
| Affiliation |
Tata Memorial Hospital |
| Address |
HBB-1111, Department of Medical Oncology-Pediatric Division. Dr. Ernest Borges Road. Parel.
Mumbai MAHARASHTRA 400012 India |
| Phone |
9004300356 |
| Fax |
|
| Email |
chetandhamne@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Chetan Dhamne |
| Designation |
Professor, Medical Oncology-Pediatrics |
| Affiliation |
Tata Memorial Hospital |
| Address |
HBB-1111, Department of Medical Oncology-Pediatric Division. Dr. Ernest Borges Road. Parel.
Mumbai MAHARASHTRA 400012 India |
| Phone |
9004300356 |
| Fax |
|
| Email |
chetandhamne@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Shubham Kumar |
| Designation |
Senior Resident |
| Affiliation |
Tata Memorial Hospital |
| Address |
OPD-88, Ground Floor,
Main Building,
Tata Memorial Hospital
Dr. Ernest Borges Road. Parel.
Mumbai MAHARASHTRA 400012 India |
| Phone |
9582998549 |
| Fax |
|
| Email |
subhamkumarht@gmail.com |
|
|
Source of Monetary or Material Support
|
| Foundation S (My Child Matters Program)
46 avenue de la Grande Armée 75017 Paris, France |
|
|
Primary Sponsor
|
| Name |
Dr. CHETAN DHAMNE |
| Address |
HBB-1111, Department of Medical Oncology-Pediatric Division. Dr. Ernest Borges Road. Parel. |
| Type of Sponsor |
Other [Self] |
|
|
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 CHETAN DHAMNE |
Tata Memorial Hospital |
Room no. 1111, Homi Bhabha Block, Department of Medical Oncology-Pediatrics, Tata Memorial Hospital
Dr. Ernest Borges Road
Parel Mumbai 400012 Mumbai MAHARASHTRA |
9004300356
chetandhamne@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee-I, IEC Ofiice, Dr E Borges Marg, Parel East, Mumbai 400012 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C910||Acute lymphoblastic leukemia [ALL], (2) ICD-10 Condition: C81||Hodgkin lymphoma, (3) ICD-10 Condition: C85||Other specified and unspecified types of non-Hodgkin lymphoma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
1.All patients with acute lymphoblastic leukemia/Lymphoma less than 15 years of age at the time of registration.
2. A parent/caretaker who understands the basic functioning of internet and committed enough to follow dose adjustment as communicated.
3. Written informed consent according to institutional guidelines. |
|
| ExclusionCriteria |
| Details |
Unwillingness to participate in the study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To determine the feasibility of using a web-based application for monitoring maintenance therapy in
patients with newly diagnosed acute lymphoblastic leukemia/lymphoma. |
The web application will be introduced to the patients after initiation of the maintenance therapy. The inputs and outputs from users are expected at 15 days interval. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the Health Related- Quality Of Life (HR-QOL) in children on maintenance therapy |
The web application will be introduced to the patients after initiation of the maintenance therapy. |
To assess compliance to maintenance therapy in children with acute lymphoblastic
leukemia/lymphoma. |
The web application will be introduced to the patients after initiation of the maintenance therapy. The inputs and outputs from users are expected at 15 days interval. |
| To assess adherence of medications during maintenance therapy |
The web application will be introduced to the patients after initiation of the maintenance therapy. The inputs and outputs from users are expected at 15 days interval. |
| Explore impact of dose intensity of maintenance therapy |
The web application will be introduced to the patients after initiation of the maintenance therapy. The inputs and outputs from users are expected at 15 days interval. |
| To study the social impact of maintenance therapy on patient and families |
The web application will be introduced to the patients after initiation of the maintenance therapy. The inputs and outputs from users are expected at 15 days interval. |
|
|
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)
|
22/12/2025 |
| 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="5" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
The treatment of Acute Lymphoblastic Leukemia (ALL) in children lasts for 2–2.5 years,
which consists of an initial 6–7 months of intensive therapy consisting of injections and oral
chemotherapy, followed by 2 years of a maintenance phase, which usually consists of oral
chemotherapy in the form of daily administration of oral tablets. Most of the maintenance
therapy is administered at home, allowing the child to return to normal life, including school
and regular activities. Children have regular blood tests to monitor their blood counts and the
effect of the medication. The chemotherapy doses are then adjusted based on these results
to maintain appropriate blood counts.
Our study explores the feasibility of using a web-based mobile application to review the
blood tests done by the children at their home and subsequently guide the dosing of
medication. We are also looking at the quality of life experienced by the children once the
child goes back to their home and rejoins school. We are looking forward to enrolling about
1000 patients through our mobile application service, who would be included in our study.
Through this study, we look forward to streamlining and standardising the phase of
maintenance therapy in the treatment of acute leukemia and identifying factors responsible
for the decrease in compliance and adherence to treatment, as well as the low quality of life
experienced by the children and their parents once they return home. |