Clinical trial · Observational
InterNatIonal CHildhood Leukemia Microbiome/MEtabolome Cohort
Multi-National Nutritional Biobanking Program in Pediatric Oncology InterNatIonal CHildhood Leukemia Microbiome/MEtabolome Cohort
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Lymphoblastic Leukemia | Acute Lymphoblastic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Genetic Predisposition | — | UNRESOLVED | — |
| Microtia | — | UNRESOLVED | — |
| Nutrition Aspect of Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| No intervention | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (6)
- measure
- 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.
- timeFrame
- 7 years
- measure
- Collect sociodemographic data at sequential timepoints during treatment for ALL.
- timeFrame
- 7 years
- measure
- Collect dietary data at sequential timepoints during treatment for ALL.
- timeFrame
- 7 years
- measure
- Collect physical activity data at sequential timepoints during treatment for ALL.
- timeFrame
- 7 years
- measure
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 3 Years
- Maximum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available