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NCT05929976 | RECRUITING | Acute Lymphoblastic Leukemia


InterNatIonal CHildhood Leukemia Microbiome/MEtabolome Cohort
Sponsor:

Columbia University

Information provided by (Responsible Party):

Elena Ladas

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.

Condition or disease

Acute Lymphoblastic Leukemia

Nutrition Aspect of Cancer

Microtia

Genetic Predisposition

Intervention/treatment

No intervention

Study Type : OBSERVATIONAL
Estimated Enrollment : 4900 participants
Official Title : Multi-National Nutritional Biobanking Program in Pediatric Oncology InterNatIonal CHildhood Leukemia Microbiome/MEtabolome Cohort
Actual Study Start Date : 2022-10-26
Estimated Primary Completion Date : 2029-10-01
Estimated Study Completion Date : 2029-10-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 3 Years to 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.

InterNatIonal CHildhood Leukemia Microbiome/MEtabolome Cohort

Location Details

NCT05929976


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How to Participate

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Locations


ACTIVE NOT RECRUITING

United States, New York

Columbia University Irving Medical Center

New York, New York, United States, 10032

RECRUITING

Brazil,

Children's Cancer Hospital de Barretos

Barretos, Brazil,

RECRUITING

Brazil,

Child Cancer Treatment Institute (Itaci)

São Paulo, Brazil,

RECRUITING

Guatemala,

National Unit of Pediatric Oncology

Guatemala City, Guatemala,

RECRUITING

Honduras,

School hospital

Tegucigalpa, Honduras,

NOT YET RECRUITING

India,

Post-Graduate Institute of Medical Education and Research (PGIMER)

Chandigarh, India,

RECRUITING

Tanzania,

Muhumbili Hospital

Dar is Salaam, Tanzania,

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