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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.

Circulating metabolic signatures as a superior alternative to Absolute Blast Count (ABC) to assess the prognosis of pediatric Acute Lymphoblastic Leukaemia (ALL) - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2024/01/061909
Enrollment
60
Registered
2024-01-29
Start date
Unknown
Completion date
Unknown
Last updated
2024-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C910- Acute lymphoblastic leukemia [ALL]

Interventions

Control Intervention1: NIL: NIL since it is an OBSERVATIONAL study.

Sponsors

Other
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
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.Timepoint: 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

MeasureTime frame
Development of a metabolomic pattern as a cheap, reliable alternative for predicting the prognosis and possibility of steroid resistance.Timepoint: 18 months.

Countries

India

Contacts

Public ContactArjun Asok

Manipal Academy of Higher Education, Manipal

arjun.asok@manipal.edu9496818436

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026