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Trial Title:
InterNatIonal CHildhood Leukemia Microbiome/MEtabolome Cohort
NCT ID:
NCT05929976
Condition:
Acute Lymphoblastic Leukemia
Nutrition Aspect of Cancer
Microtia
Genetic Predisposition
Conditions: Official terms:
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Congenital Microtia
Genetic Predisposition to Disease
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
No intervention
Description:
No intervention
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.
Criteria for eligibility:
Study pop:
Children and adolescents diagnosed with acute lymphoblastic leukemia
Sampling method:
Non-Probability Sample
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.
Gender:
All
Minimum age:
3 Years
Maximum age:
18 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Columbia University Irving Medical Center
Address:
City:
New York
Zip:
10032
Country:
United States
Status:
Active, not recruiting
Facility:
Name:
Hospital de Cancer Infanto Juvenil de Barretos
Address:
City:
Barretos
Country:
Brazil
Status:
Recruiting
Contact:
Last name:
Mariana Mura
Phone:
+55 17 3321-5400
Email:
marianamurra05@gmail.com
Facility:
Name:
Instituto de Tratamento do Câncer Infantil (ITACI)
Address:
City:
São Paulo
Country:
Brazil
Status:
Recruiting
Contact:
Last name:
Karina Viani, PhD, RD
Phone:
+5511993038746
Email:
karina.viani@hc.fm.usp.br
Facility:
Name:
Unidad Nacional De Oncologia Pediatrica
Address:
City:
Guatemala City
Country:
Guatemala
Status:
Recruiting
Contact:
Last name:
Federico Antillon Klussmann, MD
Phone:
+50223289600
Email:
fantillo@ufm.edu
Facility:
Name:
Hospital Escuela
Address:
City:
Tegucigalpa
Country:
Honduras
Status:
Recruiting
Contact:
Last name:
Ligia Fu
Phone:
+504 2232-2322
Email:
ligiafucarrasco@yahoo.com
Facility:
Name:
Post-Graduate Institute of Medical Education and Research (PGIMER)
Address:
City:
Chandigarh
Country:
India
Status:
Not yet recruiting
Contact:
Last name:
Amita Trehan, MD
Phone:
+91 172 274 7585
Email:
amita911@gmail.com
Facility:
Name:
Muhumbili Hospital
Address:
City:
Dar es Salaam
Country:
Tanzania
Status:
Recruiting
Contact:
Last name:
Primus Ewald
Phone:
+255767944827
Email:
drprimus@wearetlm.org
Start date:
October 26, 2022
Completion date:
October 1, 2029
Lead sponsor:
Agency:
Columbia University
Agency class:
Other
Collaborator:
Agency:
International Agency for Research on Cancer
Agency class:
Other
Source:
Columbia University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05929976
