Investigating nutrition's impact on childhood cancer outcomes
Southern European Prospective Investigation Into Childhood Cancer and Nutrition (EPICkids)
Columbia University · NCT05375617
This study is trying to see how nutrition affects the health and recovery of children with leukemia and brain tumors in Southern Europe.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1400 (estimated) |
| Ages | 3 Years to 21 Years |
| Sex | All |
| Sponsor | Columbia University (other) |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT05375617 on ClinicalTrials.gov |
What this trial studies
The EPICkids initiative aims to establish a comprehensive resource on nutritional status among children and adolescents with acute lymphoblastic leukemia (ALL) and favorable biology brain tumors in Southern Europe. This observational study will collect data on lifestyle behaviors, sociodemographic factors, and quality of life, correlating these indicators with clinical outcomes. A biorepository of specimens will be created to support future research on nutrition and childhood cancer. The study plans to recruit 900 patients with ALL and 1400 with brain tumors over five years, gathering data at systematic timepoints throughout treatment.
Who should consider this trial
Good fit: Ideal candidates are children and adolescents aged 3 to 21 years newly diagnosed with acute lymphoblastic leukemia or favorable biology brain tumors.
Not a fit: Patients with other types of cancer or those outside the specified age range may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved nutritional guidelines and treatment outcomes for children with cancer.
How similar studies have performed: Other studies have shown the importance of nutrition in cancer treatment, suggesting that this approach could yield meaningful insights.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
New York, New York
- Columbia University Irving Medical Center — New York, New York, United States (RECRUITING)
Study contacts
- Principal investigator: Elena J Ladas, PhD, RD — Columbia University
- Study coordinator: Michelle Walters
- Email: mw3328@cumc.columbia.edu
- Phone: 2128514995
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Acute Lymphoblastic Leukemia, Brain Tumor