European Prospective Investigation Into Childhood Cancer

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	3 Years - 21 Years
Gender	All

More 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05375617
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Columbia University
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Acute Lymphoblastic Leukemia, Brain Tumor

Additional Details

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. We will also create a prospective biorepository of specimens (stool, blood) obtained at diagnosis, during treatment, at the end of treatment, and after treatment among children and adolescents undergoing treatment for ALL and favorable biology brain tumors. We plan to recruit 900 patients with ALL and 1400 patients with a favorable biology brain tumor over five years. Eligible patients will be between 3 and 21 years of age receiving standard treatment at one of the participating institutions. Data will be collected at systematic timepoints over the study period and include demographics, food security, clinical data and disease characteristics, quality of life, physical activity, dietary intake, and nutritional anthropometric data. Blood and stool specimens will be collected at each timepoint throughout the study period.

Arms & Interventions

Arms

: Acute lymphoblastic leukemia cohort

: Brain tumor cohort

Interventions

Other: - Observational

No intervention

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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