Multi-National Nutritional Biobanking Program in Pediatric Oncology InterNatIonal CHildhood Leukemia Microbiome/MEtabolome Cohort

Status: Recruiting
Location: See all (8) locations...
Intervention Type: Other
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 3
Maximum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
New York
Columbia University Irving Medical Center
ACTIVE_NOT_RECRUITING
New York
Other Locations
Brazil
Hospital de Cancer Infanto Juvenil de Barretos
RECRUITING
Barretos
Instituto de Medicina Integral Prof. Fernando Figueira (IMIP)
RECRUITING
Recife
Instituto de Tratamento do Câncer Infantil (ITACI)
RECRUITING
São Paulo
Guatemala
Unidad Nacional De Oncologia Pediatrica
RECRUITING
Guatemala City
Honduras
Hospital Escuela
RECRUITING
Tegucigalpa
India
Post-Graduate Institute of Medical Education and Research (PGIMER)
RECRUITING
Chandigarh
United Republic of Tanzania
Muhumbili Hospital
RECRUITING
Dar Es Salaam
Contact Information
Primary
Elena Ladas, PhD, RD
ejd14@cumc.columbia.edu
+12123057835
Backup
Michelle Walters, MS, RD
mw3328@cumc.columbia.edu
+12128514995
Time Frame
Start Date: 2022-10-26
Estimated Completion Date: 2029-10-01
Participants
Target number of participants: 4900
Sponsors
Leads: Columbia University
Collaborators: International Agency for Research on Cancer

This content was sourced from clinicaltrials.gov