InterNatIonal CHildhood Leukemia Microbiome/MEtabolome Cohort

Last updated: June 25, 2024
Sponsor: Columbia University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Lymphoproliferative Disorders

Leukemia

Platelet Disorders

Treatment

No intervention

Clinical Study ID

NCT05929976
AAAU1407
  • Ages 3-18
  • All Genders

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.

Eligibility Criteria

Inclusion

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 acuteleukemia confirmed by pathology report.

  • Patients must be receiving treatment at one of the participating centers.

Exclusion

Exclusion Criteria:

  • Patients receiving hematopoietic cell transplant.

Study Design

Total Participants: 4900
Treatment Group(s): 1
Primary Treatment: No intervention
Phase:
Study Start date:
October 26, 2022
Estimated Completion Date:
October 01, 2029

Connect with a study center

  • Hospital de Cancer Infanto Juvenil de Barretos

    Barretos,
    Brazil

    Active - Recruiting

  • Instituto de Tratamento do Câncer Infantil (ITACI)

    São Paulo,
    Brazil

    Active - Recruiting

  • Unidad Nacional De Oncologia Pediatrica

    Guatemala City,
    Guatemala

    Active - Recruiting

  • Hospital Escuela

    Tegucigalpa,
    Honduras

    Active - Recruiting

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

    Chandigarh,
    India

    Site Not Available

  • Muhumbili Hospital

    Dar es Salaam,
    Tanzania

    Active - Recruiting

  • Columbia University Irving Medical Center

    New York, New York 10032
    United States

    Site Not Available

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