Understanding Childhood Leukemia and Nutrition

This observational study, called the InterNatIonal CHildhood Leukemia Microbiome/MEtabolome Cohort, aims to learn more about how nutrition affects children and adolescents with Acute Lymphoblastic Leukemia (ALL). Researchers will collect information and samples (like stool and blood) at different times during treatment and up to one year after treatment ends. This will help create a valuable resource for future studies on how cancer progresses, how patients respond to treatment, and any long-term effects. This study is not testing a new intervention; instead, it's gathering information to better understand the role of nutrition. You may be able to join if you are between 3 and 18 years old, have been recently diagnosed with B-cell or T-cell ALL (a type of blood cancer), and are receiving treatment at a participating hospital. The study plans to enroll about 4900 participants, but its current recruitment status is unclear.

Study design
This is an observational study, meaning no new interventions are being tested. It aims to enroll approximately 4900 participants.
What's involved
Participants will provide biological samples (stool, blood) and sociodemographic and dietary data at diagnosis, end of induction, beginning of maintenance, end of treatment, and one year after treatment.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to one year after treatment ends.

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NCT05929976

InterNatIonal CHildhood Leukemia Microbiome/MEtabolome Cohort

Recruiting
Not specifiedAges 3–18Observational
Columbia University
~4,900 participants
Updated 2025-07-22 on ClinicalTrials.gov
What's tested:No intervention

At a glance

Recruiting sites
7 of 8 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Create a prospective multinational biorepository of pediatric specimens (stool, blood) obtained at diagnosis, end of induction, beginning of maintenance, end of treatment, and 1-year after treatment among children/adolescents with ALL.
Measured over 7 years
+5 more outcomes measured
Acute Lymphoblastic Leukemia
Nutrition Aspect of Cancer
Microtia
Genetic Predisposition
8 sites across 6 states
Brazil3
New York1
Guatemala1
Honduras1
India1
Dar es Salaam Region1

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Eligibility criteria

Inclusion

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.
  • Create a prospective multinational biorepository of pediatric specimens (stool, blood) obtained at diagnosis, end of induction, beginning of maintenance, end of treatment, and 1-year after treatment among children/adolescents with ALL.7 years
  • Collect sociodemographic data at sequential timepoints during treatment for ALL.7 years
  • Collect dietary data at sequential timepoints during treatment for ALL.7 years
  • Collect physical activity data at sequential timepoints during treatment for ALL.7 years
  • Collect clinical information (disease characteristics, treatment-related toxicities, survival) at sequential timepoints during treatment for ALL to accompany the biorepository of blood and stool specimens.7 years
  • Collect nutritional anthropometrics at sequential timepoints during treatment for ALL to accompany the biorepository of blood and stool specimens.7 years