[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100630115":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":10,"centralContacts":23,"locations":10,"responsibleParty":34,"collaborators":10,"id":36,"slug":37,"hasResults":38,"nctId":39,"briefTitle":40,"officialTitle":41,"acronym":42,"eligibilityCriteria":43,"healthyVolunteers":44,"sex":45,"minAge":10,"maxAge":46,"enrollmentInfo":47,"targetDuration":10,"studyType":50,"phases":10,"briefSummary":51,"conditions":52,"keywords":54,"overallStatus":62,"whyStopped":10,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":10},{"fullName":5,"class":6},"Assistance Publique - Hôpitaux de Paris","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"ALL patients",null,"Children and adolescents (\\\u003C18 years) with newly diagnosed B-cell or T-cell acute lymphoblastic leukemia without BCR::ABL1 rearrangement (and without KMT2A rearrangement in infants), included before initiation of steroid therapy or chemotherapy.",[13],"Other: Biological sample collection",{"label":15,"type":10,"description":16,"interventionNames":17},"Healthy control participants","Children and adolescents (\\\u003C18 years) undergoing blood sampling for HLA typing for a sibling with leukemia.",[13],[19],{"type":6,"name":20,"description":21,"armGroupLabels":22,"otherNames":10},"Biological sample collection","Additional peripheral blood samples will be collected during treatment and follow-up for cell-free DNA analysis. Residual samples from bone marrow and cerebrospinal fluid collected as part of standard clinical care will also be analyzed.",[9,15],[24,30],{"name":25,"role":26,"phone":27,"phoneExt":28,"email":29},"Marion Strullu, MD PhD","CONTACT","+330140035388","+33","marion.strullu@aphp.fr",{"name":31,"role":26,"phone":32,"phoneExt":28,"email":33},"Jérôme Lambert, MD PhD","+330142499742","jerome.lambert@u-paris.fr",{"type":35,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100630115","study-of-cell-free-dna-in-children-and-adolescents-with-acute-lymphoblastic-leukemia-100630115",false,"NCT07483476","Study of Cell-free DNA in Children and Adolescents With Acute Lymphoblastic Leukemia","Etude de l'ADN Libre Circulant Dans Les leucémies Aigues Lymphoblastiques de l'Enfant et de l'Adolescent","CIRCALL","Inclusion Criteria:\n\nALL population\n\n* Age \\\u003C 18 years\n* Newly diagnosed B-cell or T-cell acute lymphoblastic leukemia\n* Absence of BCR::ABL1 rearrangement\n* For infants (\\\u003C12 months), absence of KMT2A rearrangement\n* Inclusion before initiation of corticosteroid therapy or chemotherapy\n* Written informed consent from legal guardians\n* Affiliation to a national health insurance system Control population\n* Age \\\u003C 18 years\n* Undergoing blood sampling for HLA typing in the context of bone marrow donor evaluation\n* Sibling of a patient with leukemia\n* Written informed consent from legal guardians\n* Affiliation to a national health insurance system\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding patients\n* Patients not affiliated with a health insurance system",true,"ALL","18 Years",{"count":48,"type":49},205,"ESTIMATED","OBSERVATIONAL","Minimal residual disease (MRD) monitoring is a key prognostic factor in pediatric acute lymphoblastic leukemia (ALL). Currently, MRD assessment relies mainly on cellular DNA obtained from bone marrow aspirates. Although highly informative, this approach has limitations, including the need for invasive procedures and the fact that it reflects only the bone marrow compartment.\n\nTumor cells release fragments of genomic DNA into the bloodstream, known as circulating cell-free DNA (cfDNA). In solid tumors, cfDNA analysis has emerged as a valuable non-invasive biomarker for disease monitoring and treatment response. Recent studies have shown that cfDNA is detectable in pediatric ALL.\n\nThis study aims to investigate whether plasma cfDNA analysis could represent an alternative or complementary approach to bone marrow-based MRD assessment. cfDNA may better reflect the global tumor burden across the entire body and allow more frequent longitudinal monitoring during treatment.\n\nThe primary objective is to assess the correlation between MRD measured in plasma cfDNA and MRD measured in bone marrow cellular DNA at two key timepoints of treatment: the end of induction (Day 29) and the end of consolidation (Day 71-78).\n\nSecondary objectives include evaluating the correlation between peripheral blood cellular DNA and bone marrow MRD, describing clonal evolution using cfDNA throughout treatment and follow-up, exploring the concordance of genomic alterations detected in cfDNA and other biological compartments, assessing the prognostic value of cfDNA MRD for relapse risk and event-free survival, and characterizing cfDNA fragmentome and methylome signatures in patients compared with healthy controls.\n\nThe study will include children and adolescents with newly diagnosed ALL treated at two AP-HP pediatric hematology centers, as well as a control cohort of healthy children undergoing HLA typing for sibling stem cell transplant.",[53],"Acute Lymphoblastic Leukemia ALL",[55,56,57,58,59,60,61],"Pediatric acute lymphoblastic leukemia","Minimal residual disease","Cell-free DNA","Liquid biopsy","Fragmentomics","Methylome","Clonal evolution","NOT_YET_RECRUITING","2026-03-16",{"date":65,"type":66},"2026-03-19","ACTUAL",{"date":68,"type":49},"2026-04-01",{"date":70,"type":49},"2034-04-01",{"name":5,"class":6}]