RecruitingNCT05929976

InterNatIonal CHildhood Leukemia Microbiome/MEtabolome Cohort

Multi-National Nutritional Biobanking Program in Pediatric Oncology InterNatIonal CHildhood Leukemia Microbiome/MEtabolome Cohort


Sponsor

Columbia University

Enrollment

4,900 participants

Start Date

Oct 26, 2022

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Min Age: 3 YearsMax Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This international study collects gut bacteria (microbiome) and urine/blood samples from children with leukemia to understand how the microbiome changes during treatment and whether those changes affect how well treatment works. **You may be eligible if...** - Your child is between 3 and 18 years old - They have been newly diagnosed with acute lymphoblastic leukemia (ALL) or mixed phenotype acute leukemia - They are being treated at one of the participating hospitals **You may NOT be eligible if...** - Your child is receiving or has received a bone marrow/stem cell transplant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERNo intervention

No intervention


Locations(8)

Columbia University Irving Medical Center

New York, New York, United States

Hospital de Cancer Infanto Juvenil de Barretos

Barretos, Brazil

Instituto de Medicina Integral Prof. Fernando Figueira (IMIP)

Recife, Brazil

Instituto de Tratamento do Câncer Infantil (ITACI)

São Paulo, Brazil

Unidad Nacional De Oncologia Pediatrica

Guatemala City, Guatemala

Hospital Escuela

Tegucigalpa, Honduras

Post-Graduate Institute of Medical Education and Research (PGIMER)

Chandigarh, India

Muhumbili Hospital

Dar es Salaam, Dar es Salaam Region, Tanzania

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NCT05929976


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