Status:
RECRUITING
European Prospective Investigation Into Childhood Cancer
Lead Sponsor:
Columbia University
Collaborating Sponsors:
International Agency for Research on Cancer
Conditions:
Acute Lymphoblastic Leukemia
Brain Tumor
Eligibility:
All Genders
3-21 years
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...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 7 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 1 2031
Estimated Enrollment :
1400 Patients enrolled
Trial Details
Trial ID
NCT05375617
Start Date
July 7 2023
End Date
March 1 2031
Last Update
May 31 2025
Active Locations (1)
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1
Columbia University Irving Medical Center
New York, New York, United States, 10032