🏛️ Verified NIH Record • Updated 2025-07-17

InterNatIonal CHildhood Leukemia Microbiome/MEtabolome Cohort (NCT05929976)

Multi-National Nutritional Biobanking Program in Pediatric Oncology InterNatIonal CHildhood Leukemia Microbiome/MEtabolome Cohort

🟢 Recruiting Interventional Protocol 📊 Observational Clinical Research Sponsor: Columbia University

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: Columbia University Irving Medical Center — New York, New York

Age range: 3 Years to 18 Years

🧪 Interventions in This Study

  • No intervention (OTHER)

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria ↗

📍 All Participating Trial Locations (8 Sites)

  • Columbia University Irving Medical Center — New York, New York
  • 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,
  • Unidad Nacional De Oncologia Pediatrica — Guatemala City,
  • Hospital Escuela — Tegucigalpa,
  • Post-Graduate Institute of Medical Education and Research (PGIMER) — Chandigarh,
  • Muhumbili Hospital — Dar es Salaam, Dar es Salaam Region

📞 Contact the Study Coordinator

Phone: (212) 305-7835

Email: ejd14@cumc.columbia.edu

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗