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European Prospective Investigation Into Childhood Cancer

Southern European Prospective Investigation Into Childhood Cancer and Nutrition (EPICkids)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
3 Years to 21 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 5 years

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "We plan to recruit 900 patients with ALL and 1400 patients with a favorable biology brain tumor over five years."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

EPICkids studies how nutrition and lifestyle relate to cancer treatment results in children and young adults ages 3 to 21. It is for people with newly diagnosed acute lymphoblastic leukemia (ALL), a blood cancer, or certain brain tumors at study centers in Spain, Greece, and Italy. The study will track nutrition and lifestyle and collect blood and stool samples over time.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be 3 to 21 years old when agreeing to join.
  • Have newly diagnosed B-cell ALL, T-cell ALL, or mixed phenotype acute leukemia, confirmed by tests that identify cancer cell types.
  • Or have a newly diagnosed brain tumor in the study’s eligible group: low-grade glioma, medulloblastoma, ependymoma, pituitary tumor, or germ cell tumor. Tests must confirm the diagnosis.
  • Receive treatment at a study center.
  • For ALL, receive standard leukemia treatment. Patients may be on a clinical trial or follow a clinical trial treatment plan.
  • For brain tumors, receive standard treatment. A transplant using the patient’s own stem cells is allowed.
  • For ALL, a parent or guardian must give permission within 3 working days of diagnosis. The patient must also agree when required.
  • For brain tumors, permission and any required patient agreement must happen before chemotherapy, radiation, or a stem cell transplant.

Who can't join

  • Cancer has returned or is getting worse. An exception is a low-grade glioma that cannot be removed by surgery and is getting worse.
  • Have had another separate cancer.
  • Have another health condition that may affect nutrition, growth, or the mix of germs in the gut, such as Down syndrome, a metabolic disorder, or celiac disease.
  • Have an inherited condition that may affect nutrition or growth.
  • For ALL, plan to receive a blood-forming stem cell transplant.
  • Have mixed lineage leukemia treated with an acute myeloid leukemia (AML) treatment plan.
  • For brain tumors, plan to have only monitoring or surgery.
  • Have an atypical teratoid/rhabdoid tumor (ATRT) or a high-grade glioma, which are types of brain tumors.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (1)

NY