Can what kids eat during cancer treatment change outcomes? new study aims to find out
NCT ID NCT05375617
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study follows 1,400 children and teens (ages 3-21) in Southern Europe with acute lymphoblastic leukemia or certain brain tumors. Researchers will track their diet, lifestyle, and quality of life over time to see how these factors relate to treatment side effects and survival. The goal is to create better nutrition guidelines for young cancer patients.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 1,400 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2023
- Expected to finish
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Mar 2031
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Southern European children and adolescents ages 3-21 years of age with acute lymphoblastic leukemia and favorable biology brain tumors.
- Ages
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3 to 21 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Columbia University Irving Medical Center
RECRUITINGNew York, New York, 10032, United States
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