Taking people in IndiaNo phase

Collects nutrition and health samples from children with leukemia

Builds a biobank of data and samples from children with leukemia during treatment.

Key facts

Who runs it: Columbia University
Where: Chandigarh, IndiaSee the siteAlso in 5 other countries, 7 sites
Trial code: NCT05929976
Registry title: InterNatIonal CHildhood Leukemia Microbiome/MEtabolome Cohort
Status: Recruiting
People taking part: 4,900 people, planned
Started: 26 Oct 2022
Expected to end: 1 Oct 2029
Type of study: Observational
Record updated: 22 July 2025

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for children and teenagers who have just been diagnosed with a type of acute leukemia and are treated at a taking-part center. It collects data and samples to study nutrition.

Age: 3 years to 18 years at the time of consent.
Sex: All sexes can join.
Disease stage: Newly diagnosed B-cell or T-cell acute lymphoblastic leukemia (ALL), or mixed phenotype acute leukemia, confirmed by a pathology report.

Main reasons for not taking part

Patients receiving a hematopoietic cell transplant

The registry criteria, word for word

Show all 4 criteriaShow less

Who can take part

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

Who cannot take part

Patients receiving hematopoietic cell transplant

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

Are you between 3 and 18 years old?

Where in India

Also in 5 other countries, 7 sites

Post Graduate Institute of Medical Education and Research (PGIMER)Chandigarh, IndiaContact: Amita Trehan, MDTaking people

About the trial

What the trial wants to find out

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.