Actively Recruiting
Multi-National Nutritional Biobanking Program in Pediatric Oncology InterNatIonal CHildhood Leukemia Microbiome/MEtabolome Cohort
Led by Columbia University · Updated on 2025-07-22
4900
Participants Needed
8
Research Sites
N/A
Total Duration
On this page
Sponsors
C
Columbia University
Lead Sponsor
I
International Agency for Research on Cancer
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating the nutritional status and its impact on treatment outcomes in children and adolescents newly diagnosed with B- or T-cell acute lymphoblastic leukemia or mixed phenotype acute leukemia. This observational study aims to create a biobank of clinical data and biological specimens from participants aged 3 to 18 years, enhancing understanding of cancer progression, prognosis, treatment toxicities, survivorship, and late effects, especially in low and middle income countries. Participants will have biological samples such as stool and blood collected at key treatment milestones including diagnosis, end of induction, beginning of maintenance, end of treatment, and one year post-treatment. Alongside, data on socioeconomic status, food security, diet, physical activity, and nutritional measurements like height, weight, and arm size will be gathered throughout the treatment period and follow-up. During the study, researchers will collect demographic, lifestyle, clinical, and nutritional information at various timepoints to accompany the biorepository. The main outcomes include establishing a multinational biobank and compiling comprehensive data on treatment-related toxicities, survival, and nutrition over seven years. Participant involvement includes multiple assessments and sample collections over the treatment course and one year after treatment ends.
CONDITIONS
Brief Title
InterNatIonal CHildhood Leukemia Microbiome/MEtabolome Cohort
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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.
You will not qualify if you...
- Patients receiving hematopoietic cell transplant.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 7 years
Participants provide blood and stool specimens at diagnosis, end of induction, beginning of maintenance, end of treatment, and 1-year after treatment to create a biorepository.
5 visits (in-person) over 7 years
Duration - Up to 7 years
Participants' sociodemographic, dietary, physical activity, clinical, and nutritional information is collected at multiple timepoints during treatment for ALL.
Multiple visits during treatment and follow-up over 7 years
Trial Site Locations
Total: 8 locations
1
Columbia University Irving Medical Center
New York, New York, United States, 10032
Active, Not Recruiting
2
Hospital de Cancer Infanto Juvenil de Barretos
Barretos, Brazil
Actively Recruiting
3
Instituto de Medicina Integral Prof. Fernando Figueira (IMIP)
Recife, Brazil
Actively Recruiting
4
Instituto de Tratamento do Câncer Infantil (ITACI)
São Paulo, Brazil
Actively Recruiting
5
Unidad Nacional De Oncologia Pediatrica
Guatemala City, Guatemala
Actively Recruiting
6
Hospital Escuela
Tegucigalpa, Honduras
Actively Recruiting
7
Post-Graduate Institute of Medical Education and Research (PGIMER)
Chandigarh, India
Actively Recruiting
8
Muhumbili Hospital
Dar es Salaam, Dar es Salaam Region, Tanzania
Actively Recruiting
Research Team
E
Elena Ladas, PhD, RD
M
Michelle Walters, MS, RD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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