Clinical trial Recruiting at 7 sites Observational Ages 3 to 18

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.

More Acute Lymphoblastic Leukemia trials

Quick facts

Study typeObservational
Ages3 Years to 18 Years
SexAll
Enrollment4900 (estimated)
SponsorColumbia University
Academic / other
Locations8 sites (New York, New York and 7 other locations)
StatusRecruiting
StartedOctober 26, 2022
Main results expectedOctober 1, 2029
Study endsOctober 1, 2029
Registry record updatedJuly 22, 2025
Trial IDNCT05929976 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

  • 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
  • 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.