InterNatIonal CHildhood Leukemia Microbiome/MEtabolome Cohort

Recruiting now

Conditions studied: Acute Lymphoblastic Leukemia, Nutrition Aspect of Cancer, Microtia, Genetic Predisposition

In brief

Nutritional status is a measurable and modifiable factor that is often not considered during treatment and its clinical impact undervalued due in part to the heavy demands on clinicians in low and middle income countries to deliver therapy to large numbers of patients. The proposed study will create a biobank of clinical data and biological specimens which will foster future studies on cancer progression and prognosis as well as toxicities during treatment which may impact survivorship and late-effects. Eligible patients must be between 3 years and 18 years of age at time of assent/consent, have newly diagnosed B- or T-cell acute lymphoblastic leukemia or mixed phenotype acute leukemia confirmed by pathology report, and must be receiving treatment at one of the participating centers. Patients receiving hematopoietic cell transplant will be excluded. Institutions were selected to ensure representation of several global health indicators related to nutritional status and wealth classification according to the World Bank. Data related to demographic variables (socioeconomic status, food security), lifestyle habits (diet, physical activity), nutritional anthropometrics (height, weight and arm anthropometry), and nutritional biological indices (stool and blood) will be collected at designated timepoints throughout treatment and one year after the end of treatment.

Key facts

Study ID: NCT05929976
Run by: Columbia University
People needed: 4900
Starts: 2022-10-26
Expected to finish: 2029-10-01
Last updated by the study team: 2025-07-22

Who can join

Age: 3 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

Patients receiving hematopoietic cell transplant.

Where it is running

Muhumbili Hospital — Dar es Salaam, Dar es Salaam Region, Tanzania (enrolling)
Hospital de Cancer Infanto Juvenil de Barretos — Barretos, Brazil (enrolling)
Instituto de Medicina Integral Prof. Fernando Figueira (IMIP) — Recife, Brazil (enrolling)
Instituto de Tratamento do Câncer Infantil (ITACI) — São Paulo, Brazil (enrolling)
Unidad Nacional De Oncologia Pediatrica — Guatemala City, Guatemala (enrolling)
Hospital Escuela — Tegucigalpa, Honduras (enrolling)
Post-Graduate Institute of Medical Education and Research (PGIMER) — Chandigarh, India (enrolling)
Columbia University Irving Medical Center — New York, New York, United States

Full record on ClinicalTrials.gov

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