An observational study in Acute Lymphoblastic Leukemia, Nutrition Aspect of Cancer and Microtia, sponsored by Columbia University. Recruiting at 8 sites in 6 countries. Open to participants aged 3 Years to 18 Years. Per ClinicalTrials.gov, last updated 2025-07-22.
Sponsored by Columbia University · Observational
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.
2,584 studies on the registry are indexed under Precursor Cell Lymphoblastic Leukemia-Lymphoma; 473 are open to participants now.
This study's planned enrollment of 4,900 is above the median of 108 across 400 observational studies indexed under Precursor Cell Lymphoblastic Leukemia-Lymphoma.
Browse Precursor Cell Lymphoblastic Leukemia-Lymphoma studies →Columbia University is the lead sponsor of 1,136 studies on the registry; 195 are open to participants now.
Of its 180 completed or terminated interventional studies of FDA-regulated products, 148 (82%) have results posted.
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Children and adolescents diagnosed with acute lymphoblastic leukemia
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Exclusion Criteria:
- Patients receiving hematopoietic cell transplant.
No intervention
Create a prospective multinational biorepository of pediatric specimens (stool, blood) obtained at diagnosis, end of induction, beginning of maintenance, end of treatment, and 1-year after treatment among children/adolescents with ALL.
Time frame: 7 years
Collect sociodemographic data at sequential timepoints during treatment for ALL.
Time frame: 7 years
Collect dietary data at sequential timepoints during treatment for ALL.
Time frame: 7 years
Collect physical activity data at sequential timepoints during treatment for ALL.
Time frame: 7 years
Collect clinical information (disease characteristics, treatment-related toxicities, survival) at sequential timepoints during treatment for ALL to accompany the biorepository of blood and stool specimens.
Time frame: 7 years
Collect nutritional anthropometrics at sequential timepoints during treatment for ALL to accompany the biorepository of blood and stool specimens.
Time frame: 7 years
Not enrolling at this site.
Plan to share: No
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Precursor Cell Lymphoblastic Leukemia-Lymphoma →