InterNatIonal CHildhood Leukemia Microbiome/MEtabolome Cohort

Acute Lymphoblastic Leukemia Clinical Trial

— NICHE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05929976
• Other study ID #: AAAU1407
• Status: Recruiting
• Start date: October 26, 2022
• Est. completion date: October 1, 2029

Study information

• Verified date: June 2023
• Source: Columbia University
• Contact: Elena Ladas, PhD, RD
• Phone: +12123057835
• Email: ejd14[@]cumc.columbia.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 4900
• Est. completion date: October 1, 2029
• Est. primary completion date: October 1, 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Lymphoblastic Leukemia
• Genetic Predisposition
• Genetic Predisposition to Disease
• Leukemia
• Microtia
• Nutrition Aspect of Cancer
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Other:
• No intervention
No intervention

Locations

Country	Name	City	State
Brazil	Hospital de Cancer Infanto Juvenil de Barretos	Barretos
Brazil	Instituto de Tratamento do Câncer Infantil (ITACI)	São Paulo
Guatemala	Unidad Nacional De Oncologia Pediatrica	Guatemala City
Honduras	Hospital Escuela	Tegucigalpa
India	Post-Graduate Institute of Medical Education and Research (PGIMER)	Chandigarh
Tanzania	Muhumbili Hospital	Dar es Salaam
United States	Columbia University Irving Medical Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Columbia University	International Agency for Research on Cancer

Countries where clinical trial is conducted

United States,  Brazil,  Guatemala,  Honduras,  India,  Tanzania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		7 years
Primary	Collect sociodemographic data at sequential timepoints during treatment for ALL.		7 years
Primary	Collect dietary data at sequential timepoints during treatment for ALL.		7 years
Primary	Collect physical activity data at sequential timepoints during treatment for ALL.		7 years
Primary	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.		7 years
Primary	Collect nutritional anthropometrics at sequential timepoints during treatment for ALL to accompany the biorepository of blood and stool specimens.		7 years