International Childhood Leukemia Microbiome and Metabolome Cohort
Multi-National Nutritional Biobanking Program in Pediatric Oncology InterNatIonal CHildhood Leukemia Microbiome/MEtabolome Cohort
This study is trying to see how nutrition affects treatment and recovery in children aged 3 to 18 who have just been diagnosed with acute lymphoblastic leukemia.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 4900 (estimated) |
| Ages | 3 Years to 18 Years |
| Sex | All |
| Sponsor | Columbia University Academic / other |
| Locations | 8 sites (New York, New York and 7 other locations) |
| Trial ID | NCT05929976 on ClinicalTrials.gov |
What this trial studies
This observational study aims to create a biobank of clinical data and biological specimens from children diagnosed with acute lymphoblastic leukemia (ALL) to investigate the impact of nutritional status on cancer progression and treatment outcomes. It will include patients aged 3 to 18 years who are newly diagnosed with B- or T-cell ALL or mixed phenotype acute leukemia. The study will focus on understanding how nutrition affects treatment toxicities and survivorship, particularly in low and middle-income countries. Participating centers were selected to represent diverse global health indicators related to nutrition and wealth.
Who should consider this trial
Good fit: Ideal candidates are children aged 3 to 18 years with newly diagnosed B- or T-cell acute lymphoblastic leukemia receiving treatment at participating centers.
Not a fit: Patients who are receiving hematopoietic cell transplants will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of the role of nutrition in leukemia treatment, potentially improving patient outcomes and survivorship.
How similar studies have performed: While the approach of studying the microbiome and metabolome in relation to leukemia is innovative, similar studies have shown promise in understanding the impact of nutrition on cancer treatment outcomes.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
New York, New York and 7 other locations
- Columbia University Irving Medical Center — New York, New York, United States (Active_not_recruiting)
- Hospital de Cancer Infanto Juvenil de Barretos — Barretos, Brazil (Recruiting)
- Instituto de Medicina Integral Prof. Fernando Figueira (IMIP) — Recife, Brazil (Recruiting)
- Instituto de Tratamento do Câncer Infantil (ITACI) — São Paulo, Brazil (Recruiting)
- Unidad Nacional De Oncologia Pediatrica — Guatemala City, Guatemala (Recruiting)
- Hospital Escuela — Tegucigalpa, Honduras (Recruiting)
- Post-Graduate Institute of Medical Education and Research (PGIMER) — Chandigarh, India (Recruiting)
- Muhumbili Hospital — Dar es Salaam, Dar es Salaam Region, Tanzania (Recruiting)
Study contacts
- Study coordinator: Elena Ladas, PhD, RD
- Email: ejd14@cumc.columbia.edu
- Phone: +12123057835
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.