InterNatIonal CHildhood Leukemia Microbiome/MEtabolome Cohort

Recruiting

• Conditions: Genetic Predisposition; Microtia; Nutrition Aspect of Cancer; Acute Lymphoblastic Leukemia

• Registration Number: NCT05929976
• Lead Sponsor: Columbia University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-26
• Study First Submitted: 2023-06-15
• Study First Submitted QC: 2023-06-24
• Study First Posted: 2023-07-05
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-25
• Last Update Posted: 2024-06-27
• Primary Completion: 2029-10-01
• Study Completion: 2029-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 4900

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (7)

Instituto de Tratamento do Câncer Infantil (ITACI); 🇧🇷 São Paulo, Brazil

Hospital Escuela; 🇭🇳 Tegucigalpa, Honduras

Columbia University Irving Medical Center; 🇺🇸 New York, New York, United States

Unidad Nacional De Oncologia Pediatrica; 🇬🇹 Guatemala City, Guatemala

Hospital de Cancer Infanto Juvenil de Barretos; 🇧🇷 Barretos, Brazil

Muhumbili Hospital; 🇹🇿 Dar es Salaam, Tanzania

Post-Graduate Institute of Medical Education and Research (PGIMER); 🇮🇳 Chandigarh, India