NCT05375617Recruiting
European Prospective Investigation Into Childhood Cancer
Southern European Prospective Investigation Into Childhood Cancer and Nutrition (EPICkids)
Source: ClinicalTrials.gov · Last updated 2 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 1400 (estimated)
- First submitted
- 11 May 2022
- Start date
- 7 Jul 2023
- Primary completion date
- 1 Mar 2028
- Lead sponsor
- Columbia University
- NCT number
- NCT05375617
What you commit to
- Study type: Observational
- Planned participants: 1400
- From 7 Jul 2023 to the primary completion date, 1 Mar 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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:
Other
- ALL and brain tumors:
Who the study is looking for
- 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.
Age in the registry: 3 years to 21 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Columbia University Irving Medical Center Coordinator of this site? Confirm its status | New York | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.