InterNatIonal CHildhood Leukemia Microbiome/MEtabolome Cohort

NCT05929976 | Recruiting DMC

• 1 other identifier: AAAU1407
• Study Type: observational
• Target: 4,900
• Locations: 6 countries
• Sites: 8

Brief 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.

Conditions

Acute Lymphoblastic Leukemia; Nutrition Aspect of Cancer; Microtia; Genetic Predisposition

Outcome Measures

Primary Outcomes (6)

• 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

Interventions

No intervention OTHER

No intervention

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Children and adolescents diagnosed with acute lymphoblastic leukemia

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.

Sponsors & Collaborators

• Columbia University: lead
• International Agency for Research on Cancer: collaborator

Study Sites (8)

Columbia University Irving Medical Center

New York, New York, 10032, United States

ACTIVE NOT RECRUITING

Hospital de Cancer Infanto Juvenil de Barretos

Barretos, Brazil

RECRUITING

Instituto de Medicina Integral Prof. Fernando Figueira (IMIP)

Recife, Brazil

RECRUITING

Instituto de Tratamento do Câncer Infantil (ITACI)

São Paulo, Brazil

RECRUITING

Unidad Nacional De Oncologia Pediatrica

Guatemala City, Guatemala

RECRUITING

Hospital Escuela

Tegucigalpa, Honduras

RECRUITING

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

Chandigarh, India

RECRUITING

Muhumbili Hospital

Dar es Salaam, Dar es Salaam Region, Tanzania

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Stool and blood will be collected at diagnosis, end of induction, beginning of maintenance, end of treatment, and 1 year post end of treatment

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Congenital Microtia; Genetic Predisposition to Disease

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Disease Susceptibility; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Elena Ladas, PhD, RD

CONTACT

+12123057835; ejd14@cumc.columbia.edu

Michelle Walters, MS, RD

CONTACT

+12128514995; mw3328@cumc.columbia.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 15, 2023
• First Posted: July 5, 2023
• Study Start: October 26, 2022
• Primary Completion (Estimated): October 1, 2029
• Study Completion (Estimated): October 1, 2029
• Last Updated: July 22, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

TA (1); US (1); HO (1); BR (3); GU (1); IN (1)