Actively Recruiting

Age: 3Years - 18Years
All Genders
NCT05929976

InterNatIonal CHildhood Leukemia Microbiome/MEtabolome Cohort

Led by Columbia University · Updated on 2025-07-22

4900

Participants Needed

8

Research Sites

361 weeks

Total Duration

On this page

Sponsors

C

Columbia University

Lead Sponsor

I

International Agency for Research on Cancer

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

InterNatIonal CHildhood Leukemia Microbiome/MEtabolome Cohort

Who Can Participate

Age: 3Years - 18Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 acute lymphoblastic leukemia or mixed phenotype acute leukemia confirmed by pathology report.
  • Patients must be receiving treatment at one of the participating centers.
Not Eligible

You will not qualify if you...

  • Patients receiving hematopoietic cell transplant.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 8 locations

1

Columbia University Irving Medical Center

New York, New York, United States, 10032

Active, Not Recruiting

2

Hospital de Cancer Infanto Juvenil de Barretos

Barretos, Brazil

Actively Recruiting

3

Instituto de Medicina Integral Prof. Fernando Figueira (IMIP)

Recife, Brazil

Actively Recruiting

4

Instituto de Tratamento do Câncer Infantil (ITACI)

São Paulo, Brazil

Actively Recruiting

5

Unidad Nacional De Oncologia Pediatrica

Guatemala City, Guatemala

Actively Recruiting

6

Hospital Escuela

Tegucigalpa, Honduras

Actively Recruiting

7

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

Chandigarh, India

Actively Recruiting

8

Muhumbili Hospital

Dar es Salaam, Dar es Salaam Region, Tanzania

Actively Recruiting

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Research Team

E

Elena Ladas, PhD, RD

CONTACT

M

Michelle Walters, MS, RD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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InterNatIonal CHildhood Leukemia Microbiome/MEtabolome Cohort | DecenTrialz