European Prospective Investigation Into Childhood Cancer

ConditionsAcute Lymphoblastic Leukemia Brain Tumor

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age3-21

SponsorColumbia University

About this trial

Over the last decades, research has shown that poor nutritional status can adversely impact prognosis and increase toxicities during treatment for childhood cancer. EPICkids is a collaboration between the International Initiative for Pediatrics and Nutrition, the International Agency for Research on Cancer, and sites throughout three Southern European countries (Spain, Greece, and Italy). The primary aim of EPICkids is to establish an informational resource on critical nutrition parameters wherein we can describe the trajectory of nutritional status among Southern European children and adolescents with acute lymphoblastic leukemia (ALL) and favorable biology brain tumors, investigate lifestyle behaviors, sociodemographic factors, and quality of life and correlate these indicators with clinical outcomes. The specimens obtained with the proposed study will foster future studies on nutrition and prevalent childhood cancer as well as establish a framework to develop evidence-based guidelines for European children with cancer, utilizing regional, European data. We plan to recruit 900 patients with ALL and 1400 patients with a favorable biology brain tumor over five years. Nutrition parameters and lifestyle factors will be measured at systematic timepoints over the study period. Stool and blood specimens will be collected at each timepoint. Eligible patients will be between 3 and 21 years of age.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

ALL: Patients must have newly diagnosed B-cell ALL, T-cell ALL, or mixed phenotype acute leukemia confirmed by immunophenotyping by flow cytometry.

Brain tumors: Patients must have newly diagnosed favorable biology brain tumor confirmed by either pathology report, imaging and/or biochemical studies including low-grade gliomas, medulloblastoma, ependymoma, pituitary tumors, germ cell tumors.

ALL and brain tumors: Participants may be children on a clinical trial or "as per" a clinical trial.

ALL: Patients will receive standard leukemia treatment.

Disqualifiers

Patients with relapsed or progressive disease, exclusive of patients with unresectable low-grade gliomas who have progressive disease.

Patients with history of other primary malignancy.

Patients with other medical conditions not associated with the malignancy that may interfere with nutritional status/growth and/or microbiome composition, like patients with Down's syndrome, metabolic disorders or celiac disease. Patients with genetic predisposition that may interfere with nutritional status/growth.

Patient plans to receive hematopoietic stem cell transplant.

Trial population

Southern European children and adolescents ages 3-21 years of age with acute lymphoblastic leukemia and favorable biology brain tumors.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Observational
Other intervention
No intervention

Treatment groups

1,400 Participants

are divided into 2 treatment groups

Group A: Acute lymphoblastic leukemia cohort1 intervention

Group B: Brain tumor cohort1 intervention

Trial outcomes

Primary outcomes

Evaluate the association of dietary and lifestyle variables to examine the association of nutritional status and dietary intake with side-effects from treatment and survival in children and adolescents with ALL and favorable biology brain tumors.

Time frame