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
1 other identifier
observational
430
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2018
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2022
CompletedFirst Submitted
Initial submission to the registry
July 25, 2023
CompletedFirst Posted
Study publicly available on registry
August 2, 2023
CompletedJanuary 24, 2024
July 1, 2023
3.8 years
July 25, 2023
January 23, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
event-free survival
The EFS time was calculated from the date of diagnosis to the last date of follow-up or the first event.
Between November 2018 and June 2022
Study Arms (1)
MRD positive and MRD negative groups
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.
Interventions
Calculate the 3-year EFS based on the MRD status (MRD positive and negative groups)
Eligibility Criteria
Children under the age of 18 years diagnosed with acute B-cell lymphoblastic leukemia between 2018 and 2022.
You may qualify if:
- 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.
You may not qualify if:
- B-cell acute lymphoblastic leukemia (B-ALL) patients who have not undergone high-throughput sequencing.
- Treated according to other protocols.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Children's Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310003, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
July 25, 2023
First Posted
August 2, 2023
Study Start
November 1, 2018
Primary Completion
August 31, 2022
Study Completion
August 31, 2022
Last Updated
January 24, 2024
Record last verified: 2023-07