Investigating nutrition's impact on childhood cancer outcomes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• One-day exercise test to see how brain and body react in epilepsy, cognitive disorders, Parkinson's, dementia, and related conditions

  A one-day study tests how an acute bout of exercise changes brain function and bodily signals in people with certain neurological conditions compared with healthy individuals.

  Recruiting Brigham and Women's Hospital · Boston, Massachusetts · NCT07883720

• Maintenance radiotherapy after standard glioblastoma treatment

  This study tests whether a single 2 Gy maintenance radiotherapy dose after standard treatment is safe and feasible for adults with newly diagnosed glioblastoma.

  Recruiting University of Minnesota · Minneapolis, Minnesota · NCT07831772

• Low-dose Liposomal Amphotericin B for preventing fungal infections in adults with blood cancers and prolonged neutropenia

  This study tests whether giving a daily 50 mg dose of liposomal amphotericin B can help prevent invasive fungal infections in adults with blood cancers who have prolonged low white blood cell counts.

  Recruiting Haikou Affiliated Hospital of Central South University Xiangya School of Medicine · Hainan, Hainan · NCT07763054

• Observatory of adults with Ph+ ALL receiving BCR-ABL1 inhibitors with chemotherapy, steroids, or monoclonal antibodies

  This study follows adults with Philadelphia-positive acute lymphoblastic leukemia who are being treated with a combination of BCR-ABL1 inhibitors and other therapies to see how they fare in real-world practice.

  Recruiting at 7 sites Versailles Hospital · Amiens and 22 other locations · NCT07684131

• BCB-276 CAR T therapy for DIPG in children and young adults

  This study tests BCB-276, a patient's own CAR T cells against DIPG, after standard radiation, to see if it is safe and can help extend survival.

  Recruiting at 3 sites Phase 2 BrainChild Bio, Inc · Los Angeles, California and 5 other locations · NCT07680439

• Temozolomide safety and effectiveness in adults with Grade III–IV glioma

  This study tests how safe and effective Amitzo temozolomide is in adults with Grade III or IV glioma in Iran, without a control group.

  Recruiting NanoAlvand · Tehran · NCT07675070

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.