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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 3
Maximum Age: 21
Healthy Volunteers: f
View:

⁃ 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.

Locations
United States
New York
Columbia University Irving Medical Center
RECRUITING
New York
Contact Information
Primary
Michelle Walters
mw3328@cumc.columbia.edu
2128514995
Time Frame
Start Date: 2023-07-07
Estimated Completion Date: 2031-03-01
Participants
Target number of participants: 1400
Treatments
Acute lymphoblastic leukemia cohort
Brain tumor cohort
Sponsors
Leads: Columbia University
Collaborators: International Agency for Research on Cancer

This content was sourced from clinicaltrials.gov