Study of Cell-free DNA in Children and Adolescents With Acute Lymphoblastic Leukemia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Biological sample collection.
- Who it may be relevant to
- Registry conditions: Acute Lymphoblastic Leukemia ALL. Basic parameters: up to 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Etude de l'ADN Libre Circulant Dans Les leucémies Aigues Lymphoblastiques de l'Enfant et de l'Adolescent
Overview
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. Tumor 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. This 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. The 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). Secondary 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. The 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.
Interventions
- Other 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.
Primary outcome measures
- Correlation between plasma cfDNA MRD and bone marrow MRD [Time frame: Up to day 78 (end of consolidation)]
Secondary outcome measures (12)
- Correlation between peripheral blood cellular DNA MRD and bone marrow MRD [Time frame: At day 29]
- Correlation between peripheral blood cellular DNA MRD and bone marrow MRD [Time frame: At day 78]
- Clonal evolution detected in cell-free DNA [Time frame: At day 1]
- Clonal evolution detected in cell-free DNA [Time frame: At day 4]
- Clonal evolution detected in cell-free DNA [Time frame: At day 8]
- Clonal evolution detected in cell-free DNA [Time frame: At day 15]
- Clonal evolution detected in cell-free DNA [Time frame: At day 29]
- Clonal evolution detected in cell-free DNA [Time frame: At day 78]
- Clonal evolution detected in cell-free DNA [Time frame: At end of maintenance]
- Clonal evolution detected in cell-free DNA [Time frame: 3 years after remission]
- Concordance of genomic alterations between cfDNA and other biological compartments [Time frame: At diagnosis]
- Prognostic value of cfDNA MRD [Time frame: Up to 5 years of follow-up]
Eligibility criteria
Inclusion criteria
ALL population
- Age < 18 years
- Newly diagnosed B-cell or T-cell acute lymphoblastic leukemia
- Absence of BCR::ABL1 rearrangement
- For infants (<12 months), absence of KMT2A rearrangement
- Inclusion before initiation of corticosteroid therapy or chemotherapy
- Written informed consent from legal guardians
- Affiliation to a national health insurance system Control population
- Age < 18 years
- Undergoing blood sampling for HLA typing in the context of bone marrow donor evaluation
- Sibling of a patient with leukemia
- Written informed consent from legal guardians
- Affiliation to a national health insurance system
Exclusion criteria
- Pregnant or breastfeeding patients
- Patients not affiliated with a health insurance system
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07483476 · 2025-A01461-48