International Childhood Leukemia Microbiome and Metabolome Cohort
Official title: Multi-National Nutritional Biobanking Program in Pediatric Oncology InterNatIonal CHildhood Leukemia Microbiome/MEtabolome Cohort
Run by Columbia University · NCT05929976 · Data updated 2026-11-12
This study is trying to see how nutrition affects treatment and recovery in children aged 3 to 18 who have just been diagnosed with acute lymphoblastic leukemia.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 3 Years to 18 Years |
| Sex | All |
| Enrollment | 4900 (estimated) |
| Sponsor | Columbia University Academic / other |
| Locations | 8 sites (New York, New York and 7 other locations) |
| Status | Recruiting |
| Started | October 26, 2022 |
| Main results expected | October 1, 2029 |
| Study ends | October 1, 2029 |
| Registry record updated | July 22, 2025 |
| Trial ID | NCT05929976 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are children aged 3 to 18 years with newly diagnosed B- or T-cell acute lymphoblastic leukemia receiving treatment at participating centers.
✕Probably not a fit
Patients who are receiving hematopoietic cell transplants will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to create a biobank of clinical data and biological specimens from children diagnosed with acute lymphoblastic leukemia (ALL) to investigate the impact of nutritional status on cancer progression and treatment outcomes. It will include patients aged 3 to 18 years who are newly diagnosed with B- or T-cell ALL or mixed phenotype acute leukemia. The study will focus on understanding how nutrition affects treatment toxicities and survivorship, particularly in low and middle-income countries. Participating centers were selected to represent diverse global health indicators related to nutrition and wealth.
Why it matters
Potential benefit: If successful, this study could enhance understanding of the role of nutrition in leukemia treatment, potentially improving patient outcomes and survivorship.
How similar studies have gone: While the approach of studying the microbiome and metabolome in relation to leukemia is innovative, similar studies have shown promise in understanding the impact of nutrition on cancer treatment outcomes.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients must be between 3 years and 18 years of age at time of assent/consent. * Patients must have newly diagnosed B- or T-cell ALL, or mixed phenotype acute leukemia confirmed by pathology report. * Patients must be receiving treatment at one of the participating centers. Exclusion Criteria: \- Patients receiving hematopoietic cell transplant.
Where it's running
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Hospital de Cancer Infanto Juvenil de Barretos
Barretos, Brazil Recruiting -
Instituto de Medicina Integral Prof. Fernando Figueira (IMIP)
Recife, Brazil Recruiting -
Instituto de Tratamento do Câncer Infantil (ITACI)
São Paulo, Brazil Recruiting -
Unidad Nacional De Oncologia Pediatrica
Guatemala City, Guatemala Recruiting -
Hospital Escuela
Tegucigalpa, Honduras Recruiting -
Post-Graduate Institute of Medical Education and Research (PGIMER)
Chandigarh, India Recruiting
Show 2 more locations
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Muhumbili Hospital
Dar es Salaam, Dar es Salaam Region, Tanzania Recruiting -
Columbia University Irving Medical Center
New York, New York, United States Active not recruiting
Study contacts
- Study coordinator: Elena Ladas, PhD, RD
- Email: ejd14@cumc.columbia.edu
- Phone: +12123057835
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.