Clinical trial · Observational
MRD Detection by NGS in Pediatric B-ALL
Minimal Residual Disease Detection by Next-generation Sequencing of Different Immunoglobulin Gene Rearrangements in Pediatric B-ALL
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This retrospective analysis aims to investigate pediatric patients with B-cell acute lymphoblastic leukemia who were detected for minimal residual disease (MRD) using next-generation sequencing (NGS). The study will utilize second-generation sequencing technology to analyze the rearrangement of the immunoglobulin heavy chain (IGH), immunoglobulin kappa light chain (IGK), and immunoglobulin lambda light chain (IGL) genes in these patients. Patients will be stratified based on NGS-MRD levels, and the relationship between NGS-MRD and Event-Free Survival (EFS) will be evaluated.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Lymphoblastic Leukemia, Pediatric | Childhood Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MRD | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- MRD positive and MRD negative groups
- description
- MRD postive: NGS-MRD\>=0.01% at the end of induction or \>=0.0001% at the end of consoidation. MRD negative: NGS-MRD\<0.01% at the end of induction or \<0.0001% at the end of consoidation.
- interventionNames
- Other: MRD
Primary outcomes (1)
- measure
- event-free survival
- timeFrame
- Between November 2018 and June 2022
- description
- The EFS time was calculated from the date of diagnosis to the last date of follow-up or the first event.
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Children with newly diagnosed B-ALL who undergone NGS of B-cell receptors * Children older than 1 year receive treatment according to the ZJCH-ALL-2019 protocol, while children younger than 1 year receive treatment according to the infant leukemia protocol. Exclusion Criteria: * B-cell acute lymphoblastic leukemia (B-ALL) patients who have not undergone high-throughput sequencing. * Treated according to other protocols.
References
Publications (0)
Data not yet available