Recruiting

Observational Study

Sponsor:

Columbia University

Code:

NCT05375617

Conditions

Acute Lymphoblastic Leukemia

Brain Tumor

Eligibility Criteria

Sex: All

Age: 3 - 21

Healthy Volunteers: Not accepted

Interventions

Observational

Study Details

Brief summary:

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

Acute Lymphoblastic Leukemia

Brain Tumor

Study ID

NCT05375617

Start date

Jul 7, 2023

Status verified date

May, 2026

Completion date

Mar 1, 2031

Anticipated

Primary completion date

Mar 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 3 - 21

Healthy Volunteers: Not accepted

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 Design

Enrollment

1400 participants

Anticipated

Interventions and Outcome Measures

Arms

Acute lymphoblastic leukemia cohort

Brain tumor cohort

Interventions

Observational

No intervention

Primary outcome measure

  • Evaluate the association of dietary and lifestyle variables to examine the association of nutritional status and dietary intake with side-effects from treatment and survival in children and adolescents with ALL and favorable biology brain tumors. [ Time Frame: From diagnosis to 1 year post-end of treatment ]

Central Contacts and Locations

Central contacts

Michelle Walters

2128514995mw3328@cumc.columbia.edu

Locations

Columbia University Irving Medical Center

Recruiting

New York, New York, United States, 10032

Contacts

Michelle Walters

212-851-4995mw3328@cumc.columbia.edu

Principal Investigator:

Elena J Ladas

More Information

Sponsor

Columbia University

Last update posted

Jun 2, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Columbia University on 2026-06-02.