European Prospective Investigation Into Childhood Cancer

Launched by COLUMBIA UNIVERSITY · May 11, 2022

Keywords

ClinConnect Summary

The European Prospective Investigation Into Childhood Cancer (EPICkids) is a clinical trial aimed at understanding how nutrition affects the health and treatment outcomes of children with acute lymphoblastic leukemia (ALL) and certain brain tumors. Researchers will study the nutritional status, lifestyle habits, and quality of life of young patients in Southern Europe (Spain, Greece, and Italy) to see how these factors relate to their cancer treatment and recovery. The trial plans to enroll about 2,300 children and adolescents aged 3 to 21 over the next five years, collecting important health information and samples like blood and stool to help improve future cancer care.

To be eligible for the study, children must have a newly diagnosed type of ALL or a specific type of brain tumor. Participants will receive standard cancer treatments based on their diagnosis, and the study will track their nutrition and health over time. Parents will need to provide consent for their child's participation shortly after diagnosis. This research aims to develop better nutrition guidelines for young cancer patients in Europe, helping to improve their overall health and treatment experiences.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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.
• Exclusion Criteria:
• 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.