[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05375617":3,"trial-entities:NCT05375617":100,"trial-summary:NCT05375617":104},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":22,"primary_purpose":15,"phases":23,"enrollment_info":24,"interventions":27,"primary_outcomes":34,"secondary_outcomes":38,"sex":47,"minimum_age":48,"maximum_age":49,"healthy_volunteers":50,"eligibility_criteria":51,"std_ages":67,"locations":70,"central_contacts":88,"overall_officials":91,"references":94,"see_also_links":99},"NCT05375617","AAAU1164","European Prospective Investigation Into Childhood Cancer","Southern European Prospective Investigation Into Childhood Cancer and Nutrition (EPICkids)","RECRUITING","2031-03-01","2026-05","2026-06-02","2023-07-07","Columbia University","OTHER",null,"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.","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.",[19,20],"Acute Lymphoblastic Leukemia","Brain Tumor",[],"OBSERVATIONAL",[],{"count":25,"type":26},1400,"ESTIMATED",[28],{"type":14,"name":29,"description":30,"armGroupLabels":31},"Observational","No intervention",[32,33],"Acute lymphoblastic leukemia cohort","Brain tumor cohort",[35],{"measure":36,"timeFrame":37},"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.","From diagnosis to 1 year post-end of treatment",[39,41,43,45],{"measure":40,"timeFrame":37},"Examine the association of nutritional status and quality of life in children and adolescents with ALL and favorable biology brain tumors.",{"measure":42,"timeFrame":37},"Develop evidence-based, regional guidelines on dietary intake and nutritional status in children and adolescents diagnosed with ALL and favorable biology brain tumors.",{"measure":44,"timeFrame":37},"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.",{"measure":46,"timeFrame":37},"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.","ALL","3 Years","21 Years",false,{"inclusion":52,"exclusion":60,"raw_text":66},[53,54,55,56,57,58,59],"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\u002For 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.","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.","ALL: Parents\u002Fguardians must consent and patient assent, if applicable, within three working days of diagnosis.","Brain tumors: Parents\u002Fguardians must consent and assent, if applicable, prior to initiation of chemotherapy, radiation or stem cell transplant.",[61,62,63,64,65],"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\u002Fgrowth and\u002For microbiome composition, like patients with Down's syndrome, metabolic disorders or celiac disease. Patients with genetic predisposition that may interfere with nutritional status\u002Fgrowth.","Patient plans to receive hematopoietic stem cell transplant.","Mixed lineage leukemias who receive AML-based protocols. Brain tumors: Children\u002Fadolescents who will be managed by observation or surgery only, or diagnosed with ATRT or high-grade gliomas.","Inclusion Criteria:\n\nAge: ALL and favorable biology brain tumors: Patient must be between 3 years and 21 years of age at the time of consent.\n\nDiagnosis:\n\n* ALL: Patients must have newly diagnosed B-cell ALL, T-cell ALL, or mixed phenotype acute leukemia confirmed by immunophenotyping by flow cytometry.\n* Brain tumors: Patients must have newly diagnosed favorable biology brain tumor confirmed by either pathology report, imaging and\u002For biochemical studies including low-grade gliomas, medulloblastoma, ependymoma, pituitary tumors, germ cell tumors.\n\nTreatment:\n\n* ALL and brain tumors: Participants may be children on a clinical trial or \"as per\" a clinical trial.\n* ALL: Patients will receive standard leukemia treatment.\n* 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.\n\nLocation: ALL and brain tumors: Patients must be receiving treatment at one of the participating centers.\n\nTiming:\n\n* ALL: Parents\u002Fguardians must consent and patient assent, if applicable, within three working days of diagnosis.\n* Brain tumors: Parents\u002Fguardians must consent and assent, if applicable, prior to initiation of chemotherapy, radiation or stem cell transplant.\n\nExclusion Criteria:\n\nALL and brain tumors:\n\n* Patients with relapsed or progressive disease, exclusive of patients with unresectable low-grade gliomas who have progressive disease.\n* Patients with history of other primary malignancy.\n* Patients with other medical conditions not associated with the malignancy that may interfere with nutritional status\u002Fgrowth and\u002For microbiome composition, like patients with Down's syndrome, metabolic disorders or celiac disease. Patients with genetic predisposition that may interfere with nutritional status\u002Fgrowth.\n\nALL:\n\n* Patient plans to receive hematopoietic stem cell transplant.\n* Mixed lineage leukemias who receive AML-based protocols. Brain tumors: Children\u002Fadolescents who will be managed by observation or surgery only, or diagnosed with ATRT or high-grade gliomas.",[68,69],"CHILD","ADULT",[71],{"facility":72,"status":8,"city":73,"state":73,"zip":74,"country":75,"contacts":76,"geoPoint":85},"Columbia University Irving Medical Center","New York","10032","United States",[77,82],{"name":78,"role":79,"phone":80,"email":81},"Michelle Walters","CONTACT","212-851-4995","mw3328@cumc.columbia.edu",{"name":83,"role":84},"Elena J Ladas","PRINCIPAL_INVESTIGATOR",{"lat":86,"lon":87},40.71427,-74.00597,[89],{"name":78,"role":79,"phone":90,"email":81},"2128514995",[92],{"name":93,"affiliation":13,"role":84},"Elena J Ladas, PhD, RD",[95],{"pmid":96,"type":97,"citation":98},"40911561","DERIVED","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\u002Fjournal.pone.0319110. eCollection 2025.",[],{"nct_id":4,"conditions":101,"biomarkers":103},[19,102],"Brain Neoplasm",[],{"nct_id":4,"found":105,"summary":106,"prompt_version":116},true,{"design":107,"status":108,"heading":109,"summary":110,"follow_up":111,"word_count":112,"commitments":113,"compensation":114,"drugs_mentioned":115},"This is an observational study planning to enroll 1400 participants. It is not testing a new treatment, but rather collecting information about patients.","completed","EPICkids: Understanding Nutrition and Lifestyle in Childhood Cancer","This study, called EPICkids, is looking at how nutrition and lifestyle affect children and teenagers with acute lymphoblastic leukemia (ALL) and certain brain tumors. Researchers want to understand how what you eat and your daily habits are connected to side effects from treatment and how well you recover. This is an observational study, meaning there are no interventions or treatments being tested; instead, researchers will collect information from participants. You might be able to join if you are between 3 and 21 years old and have a new diagnosis of ALL or a favorable biology brain tumor. The goal is to create a resource that helps us understand the link between nutrition, lifestyle, and outcomes for these conditions.","Information will be collected from diagnosis up to one year after the end of treatment.",118,"Not specified in the trial record.","Not stated in the trial record.",[29],"v2"]