InterNatIonal CHildhood Leukemia Microbiome/MEtabolome Cohort
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: No intervention.
- Who it may be relevant to
- Registry conditions: Acute Lymphoblastic Leukemia, Nutrition Aspect of Cancer, Microtia, Genetic Predisposition. Basic parameters: 3 years — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Brazil, Guatemala, Honduras, India +1
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Multi-National Nutritional Biobanking Program in Pediatric Oncology InterNatIonal CHildhood Leukemia Microbiome/MEtabolome Cohort
Overview
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.
Interventions
- Other No intervention
No intervention
Primary outcome measures
- 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]
- Collect sociodemographic data at sequential timepoints during treatment for ALL. [Time frame: 7 years]
- Collect dietary data at sequential timepoints during treatment for ALL. [Time frame: 7 years]
- Collect physical activity data at sequential timepoints during treatment for ALL. [Time frame: 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. [Time frame: 7 years]
- Collect nutritional anthropometrics at sequential timepoints during treatment for ALL to accompany the biorepository of blood and stool specimens. [Time frame: 7 years]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Brazil · 3 centers
- Hospital de Cancer Infanto Juvenil de Barretos — Barretos
- Instituto de Medicina Integral Prof. Fernando Figueira (IMIP) — Recife
- Instituto de Tratamento do Câncer Infantil (ITACI) — São Paulo
United States · 1 center
- Columbia University Irving Medical Center — New York
Guatemala · 1 center
- Unidad Nacional De Oncologia Pediatrica — Guatemala City
Honduras · 1 center
- Hospital Escuela — Tegucigalpa
India · 1 center
- Post-Graduate Institute of Medical Education and Research (PGIMER) — Chandigarh
Tanzania · 1 center
- Muhumbili Hospital — Dar es Salaam
Identifiers
NCT: NCT05929976 · AAAU1407