Health Condition 1: C910- Acute lymphoblastic leukemia [ALL]
Conditions
Interventions
None listed
Sponsors
Lady Tata Memorial Trust
Eligibility
Inclusion criteria
Inclusion criteria: [1] Age: 3 -15 years [2] New diagnosis of ALL [3] Diagnosis of high risk ALL
Exclusion criteria
Exclusion criteria: [1] Receipt of antibiotics (intravenous or oral) within 7 days prior to study screening. [2] Taking treatment elsewhere [3] Not consenting
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Compare the microbiome in children with ALL with that of healthy siblings for association of gut microbiome composition with risk of developing ALL.Timepoint: At baseline (before start of treatment) | — |
Secondary
| Measure | Time frame |
|---|---|
| a) Correlate with toxicity including incidence of mucositis and blood stream infections during treatment b) Determine changes in microbiome characteristics over time during treatment c) Document the prevalence of MDRO in the gut microbiome d) Correlate changes in microbiome with disease outcomes (e.g. post-induction MRD, 5-year EFS) Timepoint: 1. At baseline 2. After 14 weeks (post consolidation chemo) 3. After 29 weeks (post delayed intensification chemo) 4. After 53 weeks (Post 2nd cycle of maintenace chemo) | — |
Countries
India
Contacts
Public ContactDr Nirmalya Roy Moulik
Tata Memorial Hospital
Outcome results
None listed