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InterNatIonal CHildhood Leukemia Microbiome/MEtabolome Cohort
NCT05929976 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- OTHER No intervention
Study Locations (8)
Other
- 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
New York
- Columbia University Irving Medical Center — New York
Dar es Salaam Region
- Muhumbili Hospital — Dar es Salaam
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4,900 participants |
| Start Date | 2022-10-26 |
| Est. Completion | 2029-10-01 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05929976
The ClinicalTrials.gov registry entry for NCT05929976 describes a study currently listed as recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 4,900 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Columbia University, which has 875 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 4 conditions, with Acute Lymphoblastic Leukemia appearing as the primary indexed condition, and to 1 intervention — of which No intervention is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05929976 reports 8 study locations spanning 3 distinct geographic areas — top geographies include Other, New York, Dar es Salaam Region. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05929976 about?
NCT05929976 is a clinical study titled "InterNatIonal CHildhood Leukemia Microbiome/MEtabolome Cohort". 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...
What is the current status of trial NCT05929976?
This trial is currently recruiting. The enrollment target is 4,900 participants. The study started on 2022-10-26. Estimated completion is 2029-10-01.
What conditions does trial NCT05929976 study?
This clinical trial studies the following conditions: Acute Lymphoblastic Leukemia, Genetic Predisposition, Microtia, Nutrition Aspect of Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05929976?
The interventions under investigation include: No intervention (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05929976?
This trial is sponsored by Columbia University, which has 875 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05929976 being conducted?
This trial has 8 study locations across New York, Dar es Salaam Region. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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