NCT05929976 InterNatIonal CHildhood Leukemia Microbiome/MEtabolome Cohort
| NCT ID | NCT05929976 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Columbia University |
| Condition | Acute Lymphoblastic Leukemia |
| Study Type | OBSERVATIONAL |
| Enrollment | 4,900 participants |
| Start Date | 2022-10-26 |
| Primary Completion | 2029-10-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 4,900 participants in total. It began in 2022-10-26 with a primary completion date of 2029-10-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05929976 clinical trial?
This trial is open to participants of all sexes, aged 3 Years or older, up to 18 Years, studying Acute Lymphoblastic Leukemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05929976 currently recruiting?
Yes, NCT05929976 is actively recruiting participants. Contact the research team at ejd14@cumc.columbia.edu for enrollment information.
Where is the NCT05929976 trial being conducted?
This trial is being conducted at New York, United States, Barretos, Brazil, Recife, Brazil, São Paulo, Brazil and 4 additional locations.
Who is sponsoring the NCT05929976 clinical trial?
NCT05929976 is sponsored by Columbia University. The trial plans to enroll 4,900 participants.
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