Acute Lymphoblastic LeukemiaEPICkidsNCT05375617
European Prospective Investigation Into Childhood Cancer
An observational study of Acute Lymphoblastic Leukemia and Brain Tumor, run by Columbia University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 3 to 21 years
- Conditions the study is for
- Acute Lymphoblastic Leukemia, Brain Tumor
- What is being tested?
- Observational
- How many people
- 1,400 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jul 2023to 1 Mar 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Southern European children and adolescents ages 3-21 years of age with acute lymphoblastic leukemia and favorable biology brain tumors.
Who may be able to join
- 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.
Show all 12Show fewer
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Columbia University Irving Medical Center
New York, New York, 10032
Michelle Walters, 212-851-4995, mw3328@cumc.columbia.edu
Elena J Ladas
About this study
Official title: Southern European Prospective Investigation Into Childhood Cancer and Nutrition (EPICkids)
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.
Read the detailed description
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.
- Conditions
- Acute Lymphoblastic Leukemia, Brain Tumor
- Being tested
- Observational
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationalOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Acute lymphoblastic leukemia cohort | Not described Receives: Other: Observational | |
| Brain tumor cohort | Not described Receives: Other: Observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From diagnosis to 1 year post-end of treatment
Secondary outcomes (4)
Examine the association of nutritional status and quality of life in children and adolescents with ALL and favorable biology brain tumors.
Measured: From diagnosis to 1 year post-end of treatment
Develop evidence-based, regional guidelines on dietary intake and nutritional status in children and adolescents diagnosed with ALL and favorable biology brain tumors.
Measured: From diagnosis to 1 year post-end of treatment
Provide evidence-based, regional guidelines in order to standardize the delivery of nutritional care during and after cancer treatment for children and adolescents with ALL and favorable biology brain tumors.
Measured: From diagnosis to 1 year post-end of treatment
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.
Measured: From diagnosis to 1 year post-end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2022
- Study start7 Jul 2023
- Primary completion1 Mar 2028 (estimated)
- Study completion1 Mar 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- International Agency for Research on Cancer
- Responsible party
- Sponsor
- Investigators
- Elena J Ladas, PhD, RD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05375617
- Sponsor's protocol ID
- AAAU1164
- Acronym
- EPICkids
- Status last verified
- May 2026
- First submitted
- 11 May 2022
- Last updated
- 2 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Perganti F, Huybrechts I, Balduzzi AC, Barr R, Biondi A, Blade AL, Munoz Bravo E, Damasco E, Katsagoni CN, Kattamis A, Lassaletta A, Llopis Lera M, Llort A, Blanco Lopez J, Perez Martinez A, Massimino M, Morales La Madrid A, Moreno L, Munoz Alonso A, Nicolas G, Preziati G, Rizzari S, Della Valle S, Marquez Vega C, Walters M, Kozlakidis Z, Ladas EJ. Southern European Prospective Investigation Into Childhood Cancer and Nutrition (EPICkids): Study design and protocol. PLoS One. 2025 Sep 5;20(9):e0319110. doi: 10.1371/journal.pone.0319110. eCollection 2025.
PubMed 40911561
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Southern European Prospective Investigation Into Childhood Cancer and Nutrition (EPICkids)
- ClinicalTrials.gov ID
- NCT05375617
- Acronym / sponsor ID
- EPICkids / AAAU1164
- Conditions
- Acute Lymphoblastic Leukemia, Brain Tumor
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,400 participants (estimated)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- International Agency for Research on Cancer
- Study start
- 7 Jul 2023 (actual)
- Primary completion
- 1 Mar 2028 (estimated)
- Study completion
- 1 Mar 2031 (estimated)
- First posted
- 16 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acute lymphoblastic leukemia cohort | – | Other: Observational |
| Brain tumor cohort | – | Other: Observational |
Who may qualify
- Ages
- 3 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Southern European children and adolescents ages 3-21 years of age with acute lymphoblastic leukemia and favorable biology brain tumors.
Key inclusion criteria (12 listed)
- Age: ALL and favorable biology brain tumors: Patient must be between 3 years and 21 years of age at the time of consent.
- 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.
- 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.
Key exclusion criteria (7 listed)
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObservationalNo intervention | Other | Acute lymphoblastic leukemia cohort, Brain tumor cohort |
Primary outcome
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
4 secondary outcomes
Examine the association of nutritional status and quality of life in children and adolescents with ALL and favorable biology brain tumors.
Time frame: From diagnosis to 1 year post-end of treatment
Develop evidence-based, regional guidelines on dietary intake and nutritional status in children and adolescents diagnosed with ALL and favorable biology brain tumors.
Time frame: From diagnosis to 1 year post-end of treatment
Provide evidence-based, regional guidelines in order to standardize the delivery of nutritional care during and after cancer treatment for children and adolescents with ALL and favorable biology brain tumors.
Time frame: From diagnosis to 1 year post-end of treatment
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.
Time frame: From diagnosis to 1 year post-end of treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- Derived from this study: PubMed 40911561Perganti F, Huybrechts I, Balduzzi AC, Barr R, Biondi A, Blade AL, Munoz Bravo E, Damasco E, Katsagoni CN, Kattamis A, Lassaletta A, Llopis Lera M, Llort A, Blanco Lopez J, Perez Martinez A, Massimino M, Morales La Madrid A, Moreno L, Munoz Alonso A, Nicolas G, Preziati G, Rizzari S, Della Valle S, Marquez Vega C, Walters M, Kozlakidis Z, Ladas EJ. Southern European Prospective Investigation Into Childhood Cancer and Nutrition (EPICkids): Study design and protocol. PLoS One. 2025 Sep 5;20(9):e0319110. doi: 10.1371/journal.pone.0319110. eCollection 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Elena J Ladas, PhD, RD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Lymphoblastic Leukemia and Brain Tumor, run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michelle Walters (2128514995, mw3328@cumc.columbia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05375617, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026; AzTrials last refreshed its copy on 8 Nov 2026.