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CTRI Number  CTRI/2024/01/061909 [Registered on: 29/01/2024] Trial Registered Prospectively
Last Modified On: 12/01/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Testing the potential use of using a new biomarker found in the blood of children suffering from blood cancer to predict the severity and outcome of their disease.  
Scientific Title of Study   Circulating metabolic signatures as a superior alternative to Absolute Blast Count (ABC) to assess the prognosis of pediatric Acute Lymphoblastic Leukaemia (ALL) 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Arjun Asok 
Designation  Assistant Professor 
Affiliation  Manipal Academy of Higher Education, Manipal 
Address  Department of Biochemistry Kasturba Medical College Manipal

Udupi
KARNATAKA
576104
India 
Phone  9496818436  
Fax    
Email  arjun.asok@manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Arjun Asok 
Designation  Assistant Professor 
Affiliation  Manipal Academy of Higher Education, Manipal 
Address  Department of Biochemistry Kasturba Medical College Manipal

Udupi
KARNATAKA
576104
India 
Phone  9496818436  
Fax    
Email  arjun.asok@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Arjun Asok 
Designation  Assistant Professor 
Affiliation  Manipal Academy of Higher Education, Manipal  
Address  Department of Biochemistry Kasturba Medical College Manipal

Udupi
KARNATAKA
576104
India 
Phone  9496818436  
Fax    
Email  arjun.asok@manipal.edu  
 
Source of Monetary or Material Support  
Department of Biochemistry Kasturba Medical College, Manipal 
 
Primary Sponsor  
Name  Other  
Address  Department of Biochemistry Kasturba Medical College Manipal 
Type of Sponsor  Private medical college 
 
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 Vasudev Bhat  Kasturba Medical College Hospital, Manipal  Room No. 21 Department of Pediatric Hematology and Oncology Kasturba Medical College, Manipal
Udupi
KARNATAKA 		 9619114703

vasudev.bhat@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional EthicsCommittee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C910||Acute lymphoblastic leukemia [ALL],  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL since it is an OBSERVATIONAL study.  
 
Inclusion Criteria  
Age From  0.00 Day(s)
Age To  12.00 Year(s)
Gender  Both 
Details  Test group: Neonates, infants, and children below the age of 12 diagnosed with Acute lymphoblastic leukaemia for the first time.

Control group: Age matched children below the age of 12 years without Acute Lymphoblastic Leukemia and having normal developmental milestones.  
 
ExclusionCriteria 
Details  Test group: Children above the age of 12 years. Children with a previous diagnosis of Acute Lymphoblastic Leukaemia or under treatment.

Control group: Children with an active infection. Children with delayed developmental milestones. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Identification of individual metabolites or patterns in metabolites which will serve as a more reliable marker for prognosis of ALL than Absolute Blast Count (ABC).
2. Identification of metabolomic signatures to serve as a predictor for steroid resistance in ALL.  		 Start of the study: Baseline metabolomic signatures of patients and controls will be established.
12 weeks: A pilot data will be generated with a minimum of 10 patient and 10 control samples.
8 months: Completion of sample collection and analysis.
12 months: Generation of the complete data, statistical analysis, generation of the result.  
 
Secondary Outcome  
Outcome  TimePoints 
Development of a metabolomic pattern as a cheap, reliable alternative for predicting the prognosis and possibility of steroid resistance.   18 months. 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   01/02/2024 
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="1"
Months="0"
Days="3" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Other (Terminated) 
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   Aims:
a) To identify and validate the metabolomic markers that serve as prognostic markers of pediatric ALL. b) To identify and validate the metabolomic signatures that serve as predictive markers of steroid resistance in pediatric ALL. Objectives: a) To identify circulating baseline metabolomic signatures in pediatric ALL. b) Identify metabolomic biomarkers as an objective and superior alternative to ABC for predicting the prognosis of pediatric ALL. c) Contrast the differences in the circulating metabolomic baseline signatures in steroid sensitive and steroid resistant pediatric ALL.

Justification: Acute Lymphoblastic Leukaemia (ALL) is the commonest leukaemia in paediatric population. Glucocorticoids (GCs) hold a central role in the multi-drug regimen used to treat ALL and high dose GCs are administered from Day 1 to Day 7 (induction phase) of the treatment regimen (Inaba & Pui, 2021). Response to GCs is monitored by an absolute blast count (ABC) on Day 8 of initiation of therapy, with an ABC of >1000/L reflective of a poor prognosis and possible GC resistance. Unfortunately, ABC is a subjective assessment and inter-assessor variability is high (Hodes, et al., 2019), necessitating the need for developing an objective marker for predicting the prognosis. A metabolomic profile takes into consideration both the genomic and epigenomic aspects of an individual. Hence, the metabolomic signatures reflect changes resulting from expression of genes to epigenetic factors, providing an excellent indicator of the disease spectrum in an individual. Moreover, being an objective marker, it can be used reliably to predict treatment response and prognosis than ABC. Steroid resistance is one of the most important factors predicting a poor treatment outcome. Since steroid receptors are omnipresent, steroid resistance would result in a perturbation of circulating metabolites, quantification of which should help in developing a marker more objective than ABC.

INCLUSION CRITERIA (Test group): a) Children (either gender) below the age of 12 years diagnosed with acute lymphoblastic leukemia for the first time. b) No treatment initiated. EXCLUSION CRITERIA (Test group): a) Children (either gender) above the age of 12 years b) Already diagnosed and treatment initiated children with ALL from any hospital/clinic. INCLUSION CRITERIA (Control group): a) Children (either gender) below the age of 12 years with normal developmental milestones and no active infections/diagnosis of malignancies. EXCLUSION CRITERIA (Control group): a) Children above the age of 12 years. b) Any child with an active infection.   

Sample size: To the best of our knowledge, no studies have been done in identification of metabolomic markers for predicting the prognosis and paeditaric ALL or as a marker of steroid resistance. As such, we would like to do a pilot study recruiting a total of 30 patients with ALL and 30 age matched controls

Procedure: 
The samples will be collected from newly diagnosed cases of pediatric ALL on Day 0 (baseline) and Day 7 (last day of treatment with steroids). The sequence of events from the first day is as follows: Day 0: Patient counselling followed by collection of informed consent. This will be followd by the collection of blood sample. From vacutainer that is sent to Biochemistry department, left over serum would be collected (after the billed tests are processed) in 1.5 mL Eppendorf tubes. After labelling, these tubes will be stored at -80 degree Celcius. Blood samples sent to the Biochemistry laboratory from age-matched children (sent from Department of Pediatrics) would be taken as controls. The investigator would liason with a faculty member from Department of Pediatrics to ensure that the samples sent are appropriate to be taken for the study. A faculty from Department of Biochemistry would then anonymize the samples before handing them over to the PI. ; Day 7 (last day of treatment with steroids): From vacutainer that is sent to Biochemistry department, left over serum would be collected (after the billed tests are processed) in 1.5 mL Eppendorf tubes. After labelling, these tubes will be stored at -80 degree Celcius. Once all the samples (cases and controls) are collected, the samples will be analysed using a Gas Chromatograph – Mass Spectrometer housed in the Department of Biochemistry, Kasturba Medical College, Manipal. The following parameters will be quantified: Organic acids; Amino Acids; Fatty Acids. Once the samples are processed, the data from cases will be compared with the data from controls. Data analysis will be done using the apt statistical tool. Then ,the data will be compared to Absolute Blast Count (ABC) and a potential metabolomic marker would be identified that can be used as an objective and superior marker.  

Outcome measures: i) Establishment of reliable and superior circulating metabolomic markers consistent with the prognostic outcomes of pediatric ALL compared to ABC. ii)  Establishment of metabolomic markers predictive of glucocorticoid resistance.

 
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