NICHE: InterNatIonal CHildhood Leukemia Microbiome/MEtabolome Cohort
Study Details
Study Description
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 | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Outcome Measures
Primary Outcome Measures
- 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]
- Collect sociodemographic data at sequential timepoints during treatment for ALL. [7 years]
- Collect dietary data at sequential timepoints during treatment for ALL. [7 years]
- Collect physical activity data at sequential timepoints during treatment for ALL. [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. [7 years]
- Collect nutritional anthropometrics at sequential timepoints during treatment for ALL to accompany the biorepository of blood and stool specimens. [7 years]
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Columbia University Irving Medical Center | New York | New York | United States | 10032 |
| 2 | Hospital de Cancer Infanto Juvenil de Barretos | Barretos | Brazil | ||
| 3 | Instituto de Tratamento do Câncer Infantil (ITACI) | São Paulo | Brazil | ||
| 4 | Unidad Nacional De Oncologia Pediatrica | Guatemala City | Guatemala | ||
| 5 | Hospital Escuela | Tegucigalpa | Honduras | ||
| 6 | Post-Graduate Institute of Medical Education and Research (PGIMER) | Chandigarh | India | ||
| 7 | Muhumbili Hospital | Dar es Salaam | Tanzania |
Sponsors and Collaborators
- Columbia University
- International Agency for Research on Cancer
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- AAAU1407