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CTRI Number  CTRI/2024/09/073667 [Registered on: 09/09/2024] Trial Registered Prospectively
Last Modified On: 03/09/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   Understanding Childhood CML: Insights on Stopping vs. Continuing Imatinib Treatment 
Scientific Title of Study   A qualitative study of exploring and comparing the impact of discontinuation of tyrosine kinase inhibitors (TKI)/Imatinib vs continuing (TKI) Imatinib in childhood chronic myeloid leukemia (CML) patients: patients perspective 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mrs Savita Goswami 
Designation  Psycho-oncologist 
Affiliation  Tata Memorial Hospital 
Address  OPD 702, 7th floor, Psychology Department Golden jubilee building, Tata Memorial hospital,Parel-East

Mumbai
MAHARASHTRA
400012
India 
Phone  9820050072  
Fax    
Email  savitata@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Nirmalya Roy Moulik 
Designation  Professor 
Affiliation  Tata Memorial Hospital 
Address  OPD 88, Ground floor, Main building, Tata memorial hospital, Parel-East

Mumbai
MAHARASHTRA
400012
India 
Phone  7045991385  
Fax    
Email  roymoulik@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Nirmalya Roy Moulik 
Designation  Professor 
Affiliation  Tata Memorial Hospital 
Address  OPD 88, Ground floor, Main building, Tata memorial hospital, Parel-East


MAHARASHTRA
400012
India 
Phone  7045991385  
Fax    
Email  roymoulik@gmail.com  
 
Source of Monetary or Material Support  
Tata Memorial Hospital, Dr E-borges road, Parel-East (400012) 
 
Primary Sponsor  
Name  Tata Memorial Hospital 
Address  Tata Memorial Hospital, Dr E-borges road, Parel-East(400012),MAHARASHTRA 
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 
Mrs Savita Goswami  Tata Memorial Hospital  OPD 702, 7th floor, Psychology department, Golden jubilee building, Dr.E-Borges Road. Parel. Mumbai. Maharashtra. Pin-400012
Mumbai
MAHARASHTRA 		 9820050072

savitata@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee-II, Institutional Review Board, 3rd floor, Main Building, Tata Memorial Hospital, Dr. Ernest Borges Road, Parel. Mumbai. Pin-400012   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G||Mental Health,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  39.00 Year(s)
Gender  Both 
Details  • CML patients those who are continuing on TKI/ Imatinib, those patients in whom Imatinib is
discontinued and patients whom discontinued and restarted on TKI/Imatinib
• Age between 18-39 years and less than 15 years of age at the time of diagnosis
• Marathi, Hindi and English speaking, able to undergo 30-40 minutes in depth interview 
 
ExclusionCriteria 
Details  • Communication difficulty due to any cause or unable to give informed consent
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Patients’ perspective about TKI discontinuation  After 8 weeks from TKI discontinuation  
 
Secondary Outcome  
Outcome  TimePoints 
Not Applicable  Not Applicable 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   17/09/2024 
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="0"
Months="6"
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  

This study focuses on a rare type of blood cancer called Chronic Myeloid Leukemia (CML). The researchers want to learn how patients feel about their medicine, which is called Imatinib. Some patients have to take this medicine for a long time, and it can have side effects that affect their lives.

The researchers will talk to patients with CML who have either stopped taking the medicine or are still taking it. They want to understand how patients feel about stopping the medicine compared to those who continue with it. In this study, we will enroll patients who are in the age category of 18 to 39 years and were diagnosed with CML during their childhood.

The researchers will have friendly and relaxed interviews with the patients, asking about their experiences and thoughts related to the medicine. They want to learn if stopping the medicine makes the patients feel better or if it has any negative effects.

By listening to the patients’ stories, the researchers hope to find ways to improve the treatment for CML and make sure patients with this cancer have a better quality of life. The study will continue until the researchers have heard enough from the patients and have a good understanding of their experiences and feelings about the medicine.

 
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