Actively Recruiting
European Prospective Investigation Into Childhood Cancer
Led by Columbia University · Updated on 2025-05-31
1400
Participants Needed
1
Research Sites
399 weeks
Total Duration
On this page
Sponsors
C
Columbia University
Lead Sponsor
I
International Agency for Research on Cancer
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
European Prospective Investigation Into Childhood Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient must be between 3 and 21 years of age at the time of consent.
- Patients with newly diagnosed B-cell ALL, T-cell ALL, or mixed phenotype acute leukemia confirmed by immunophenotyping by flow cytometry.
- Patients with newly diagnosed favorable biology brain tumor confirmed by pathology report, imaging, and/or biochemical studies, including low-grade gliomas, medulloblastoma, ependymoma, pituitary tumors, germ cell tumors.
- Participants may be children on a clinical trial or following a clinical trial protocol.
- ALL patients will receive standard leukemia treatment.
- Brain tumor patients will be treated with standard approaches including surgery, chemotherapy, and radiation therapy; those receiving autologous stem cell transplantation may be included.
- Patients must be receiving treatment at one of the participating centers.
- Consent must be given within three working days of diagnosis for ALL patients.
- Consent must be given prior to start of chemotherapy, radiation, or stem cell transplant for brain tumor patients.
You will not qualify if you...
- Patients with relapsed or progressive disease, except unresectable low-grade gliomas with progressive disease.
- Patients with a history of other primary malignancy.
- Patients with medical conditions not related to the cancer that may affect nutritional status or microbiome composition, such as Down's syndrome, metabolic disorders, or celiac disease.
- Patients with genetic predispositions that may affect nutritional status or growth.
- ALL patients planning to receive hematopoietic stem cell transplant.
- Patients with mixed lineage leukemias who receive AML-based protocols.
- Brain tumor patients managed by observation or surgery only, or diagnosed with ATRT or high-grade gliomas.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Columbia University Irving Medical Center
New York, New York, United States, 10032
Actively Recruiting
Research Team
M
Michelle Walters
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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