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NCT Number: NCT05929976

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.

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Key information

Conditions

Acute Lymphoblastic Leukemia Congenital Abnormalities Congenital Microtia Congenital, Hereditary, and Neonatal Diseases and Abnormalities Disease Attributes Disease Susceptibility Ear Diseases Genetic Predisposition Genetic Predisposition to Disease Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Microtia Neoplasms Neoplasms by Histologic Type Nutrition Aspect of Cancer Otorhinolaryngologic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Precursor Cell Lymphoblastic Leukemia-Lymphoma

Age range

3 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital de Cancer Infanto Juvenil de Barretos, Barretos, Brazil

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

No intervention

Other

No intervention

Primary outcomes

  1. 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.

    Time frame: 7 years

  2. Collect sociodemographic data at sequential timepoints during treatment for ALL.

    Time frame: 7 years

  3. Collect dietary data at sequential timepoints during treatment for ALL.

    Time frame: 7 years

  4. Collect physical activity data at sequential timepoints during treatment for ALL.

    Time frame: 7 years

  5. 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.

    Time frame: 7 years

  6. Collect nutritional anthropometrics at sequential timepoints during treatment for ALL to accompany the biorepository of blood and stool specimens.

    Time frame: 7 years

Study contacts

Contact information is provided by the study sponsor or research team.

Elena Ladas, PhD, RD

CONTACT

[email protected]

+12123057835

Michelle Walters, MS, RD

CONTACT

[email protected]

+12128514995

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

  • International Agency for Research on Cancer

Registry information

Official study title

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

Acronym: NICHE

Important dates

Study start
2022
Primary completion
2029
Study completion
2029
First posted
Jul 5, 2023
Registry last updated
Jul 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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