InterNatIonal CHildhood Leukemia Microbiome/MEtabolome Cohort (NICHE)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Acute Lymphoblastic Leukemia; Nutrition Aspect of Cancer; Genetic Predisposition; Microtia
• Intervention / Treatment: Other: No intervention

• Study Type: Observational
• Enrollment (Estimated): 4900

Contacts and Locations

• Study Contact: Name: Elena Ladas, PhD, RD; Phone Number: +12123057835; Email: ejd14@cumc.columbia.edu
• Study Contact Backup: Name: Michelle Walters, MS, RD; Phone Number: +12128514995; Email: mw3328@cumc.columbia.edu

Study Locations

• Brazil
  • Barretos, Brazil
    • Recruiting
    • Hospital de Cancer Infanto Juvenil de Barretos
    • Contact: Mariana Mura; Phone Number: +55 17 3321-5400; Email: marianamurra05@gmail.com
  • Recife, Brazil
    • Recruiting
    • Instituto de Medicina Integral Prof. Fernando Figueira (IMIP)
    • Contact: Jullyana Alves; Phone Number: +55 81 99594-8420; Email: jullyana.alves@imip.org.br
  • São Paulo, Brazil
    • Recruiting
    • Instituto de Tratamento do Câncer Infantil (ITACI)
    • Contact: Karina Viani, PhD, RD; Phone Number: +5511993038746; Email: karina.viani@hc.fm.usp.br
• Guatemala
  • Guatemala City, Guatemala
    • Recruiting
    • Unidad Nacional De Oncologia Pediatrica
    • Contact: Federico Antillon Klussmann, MD; Phone Number: +50223289600; Email: fantillo@ufm.edu
• Honduras
  • Tegucigalpa, Honduras
    • Recruiting
    • Hospital Escuela
    • Contact: Ligia Fu; Phone Number: +504 2232-2322; Email: ligiafucarrasco@yahoo.com
• India
  • Chandigarh, India
    • Recruiting
    • Post-Graduate Institute of Medical Education and Research (PGIMER)
    • Contact: Amita Trehan, MD; Phone Number: +91 172 274 7585; Email: amita911@gmail.com
• Tanzania
  • Dar es Salaam, Tanzania
    • Recruiting
    • Muhumbili Hospital
    • Contact: Primus Ewald; Phone Number: +255767944827; Email: drprimus@wearetlm.org
• United States
  • New York
    • New York, New York, United States, 10032
      • Active, not recruiting
      • Columbia University Irving Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Children and adolescents diagnosed with acute lymphoblastic leukemia

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

- Patients receiving hematopoietic cell transplant.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Columbia University
• Collaborators: International Agency for Research on Cancer

Study record dates

Study Major Dates

• Study Start (Actual): October 26, 2022
• Primary Completion (Estimated): October 1, 2029
• Study Completion (Estimated): October 1, 2029

Study Registration Dates

• First Submitted: June 15, 2023
• First Submitted That Met QC Criteria: June 24, 2023
• First Posted (Actual): July 5, 2023

Study Record Updates

• Last Update Posted (Actual): July 22, 2025
• Last Update Submitted That Met QC Criteria: July 17, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Disease Attributes; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Congenital Abnormalities; Otorhinolaryngologic Diseases; Ear Diseases; Leukemia, Lymphoid; Disease Susceptibility; Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Genetic Predisposition to Disease; Congenital Microtia
• Other Study ID Numbers: AAAU1407

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No