Clinical trial NCT05929976: InterNatIonal CHildhood Leukemia Microbiome/MEtabolome Cohort
Official title: Multi-National Nutritional Biobanking Program in Pediatric Oncology InterNatIonal CHildhood Leukemia Microbiome/MEtabolome Cohort
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Lymphoblastic Leukemia
Nutrition Aspect of Cancer
Microtia
Genetic Predisposition
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: International Agency for Research on Cancer
First posted: 2023-07-05
Enrollment: 4900
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children and adolescents diagnosed with acute lymphoblastic leukemia

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.


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.

Primary outcomes:
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.
timeFrame: 7 years
measure: Collect nutritional anthropometrics at sequential timepoints during treatment for ALL to accompany the biorepository of blood and stool specimens.
timeFrame: 7 years
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Irving Medical Center
state: New York
city: Barretos
country: Brazil
facility: Hospital de Cancer Infanto Juvenil de Barretos
city: São Paulo
country: Brazil
facility: Instituto de Tratamento do Câncer Infantil (ITACI)
city: Guatemala City
country: Guatemala
facility: Unidad Nacional De Oncologia Pediatrica
city: Tegucigalpa
country: Honduras
facility: Hospital Escuela
city: Chandigarh
country: India
facility: Post-Graduate Institute of Medical Education and Research (PGIMER)
city: Dar es Salaam
country: Tanzania
facility: Muhumbili Hospital
Study officials:
References: