European Prospective Investigation Into Childhood Cancer
EPICkids
Southern European Prospective Investigation Into Childhood Cancer and Nutrition (EPICkids)
1 other identifier
observational
1,400
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2023
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 11, 2022
CompletedFirst Posted
Study publicly available on registry
May 16, 2022
CompletedStudy Start
First participant enrolled
July 7, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2031
June 2, 2026
May 1, 2026
4.7 years
May 11, 2022
May 29, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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.
From diagnosis to 1 year post-end of treatment
Secondary Outcomes (4)
Examine the association of nutritional status and quality of life in children and adolescents with ALL and favorable biology brain tumors.
From diagnosis to 1 year post-end of treatment
Develop evidence-based, regional guidelines on dietary intake and nutritional status in children and adolescents diagnosed with ALL and favorable biology brain tumors.
From diagnosis to 1 year post-end of treatment
Provide evidence-based, regional guidelines in order to standardize the delivery of nutritional care during and after cancer treatment for children and adolescents with ALL and favorable biology brain tumors.
From diagnosis to 1 year post-end of treatment
Create a prospective biorepository of specimens (stool, blood) obtained at diagnosis, during treatment, at the end of treatment, and after treatment among children and adolescents undergoing treatment for ALL and favorable biology brain tumors.
From diagnosis to 1 year post-end of treatment
Study Arms (2)
Acute lymphoblastic leukemia cohort
Brain tumor cohort
Interventions
Eligibility Criteria
Southern European children and adolescents ages 3-21 years of age with acute lymphoblastic leukemia and favorable biology brain tumors.
You may qualify if:
- Age: ALL and favorable biology brain tumors: Patient must be between 3 years and 21 years of age at the time of consent.
- Diagnosis:
- 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.
- Treatment:
- 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.
- Brain tumors: Patients will be treated depending upon standard approach with surgery, chemotherapy, radiation therapy. Patients receiving autologous stem cell transplantation as part of their regimen may be included.
- Location: ALL and brain tumors: Patients must be receiving treatment at one of the participating centers.
- Timing:
- ALL: Parents/guardians must consent and patient assent, if applicable, within three working days of diagnosis.
- Brain tumors: Parents/guardians must consent and assent, if applicable, prior to initiation of chemotherapy, radiation or stem cell transplant.
You may not qualify if:
- ALL and brain tumors:
- 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.
- ALL:
- Patient plans to receive hematopoietic stem cell transplant.
- Mixed lineage leukemias who receive AML-based protocols. Brain tumors: Children/adolescents who will be managed by observation or surgery only, or diagnosed with ATRT or high-grade gliomas.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Columbia Universitylead
- International Agency for Research on Cancercollaborator
Study Sites (1)
Columbia University Irving Medical Center
New York, New York, 10032, United States
Related Publications (1)
Perganti F, Huybrechts I, Balduzzi AC, Barr R, Biondi A, Blade AL, Munoz Bravo E, Damasco E, Katsagoni CN, Kattamis A, Lassaletta A, Llopis Lera M, Llort A, Blanco Lopez J, Perez Martinez A, Massimino M, Morales La Madrid A, Moreno L, Munoz Alonso A, Nicolas G, Preziati G, Rizzari S, Della Valle S, Marquez Vega C, Walters M, Kozlakidis Z, Ladas EJ. Southern European Prospective Investigation Into Childhood Cancer and Nutrition (EPICkids): Study design and protocol. PLoS One. 2025 Sep 5;20(9):e0319110. doi: 10.1371/journal.pone.0319110. eCollection 2025.
PMID: 40911561DERIVED
Biospecimen
Blood and stool samples
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Elena J Ladas, PhD, RD
Columbia University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 11, 2022
First Posted
May 16, 2022
Study Start
July 7, 2023
Primary Completion (Estimated)
March 1, 2028
Study Completion (Estimated)
March 1, 2031
Last Updated
June 2, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will not share