Ignite Creation Date:
2024-05-06 @ 7:19 PM
Last Modification Date:
2024-10-26 @ 3:04 PM
Study NCT ID:
NCT05973032
Status:
COMPLETED
Last Update Posted:
2024-01-24
First Post:
2023-07-25
Brief Title:
MRD Detection by NGS in Pediatric B-ALL
Sponsor:
The Childrens Hospital of Zhejiang University School of Medicine
Organization:
The Childrens Hospital of Zhejiang University School of Medicine
Study Overview
Official Title:
Minimal Residual Disease Detection by Next-generation Sequencing of Different Immunoglobulin Gene Rearrangements in Pediatric B-ALL
Status:
COMPLETED
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
Study Design Patients and Procedures This was a prospective single-center observational study conducted in children with ALL between November 2018 and June 2022 Children with newly diagnosed B-ALL who undergone NGS of B-cell receptors at the Childrens Hospital of Zhejiang University School of Medicine were included in this study
The European Group for the Immunological Characterization of Leukemias EGIL criteria were applied to diagnose and classify ALL in this study All enrolled patients were treated according to the ZJCH-ALL-2019 protocol detailed in the supplementary file This protocol was implemented in our center in September 2018 and subsequently extended to all of Zhejiang Province in 2019 In this protocol NGS-MRD was not used for patient risk stratification or treatment allocation For the detection of MRD bone marrow BM aspiration for Ig NGS was collected at diagnosis the end of induction EOI at the 5th week from the initial prednisone prephase and the end of consolidation EOC at the 13th week which was before the start of early intensification for low and intermediate risk patients and was before the start of the second course of consolidation for high-risk patients NGS-MRD was sequentially monitored every 2 to 3 months after consolidation until it was undetectable In this study NGS-MRD refers to the quantitative value of MRD detected through NGS testing which was the sum of IGH and light chain IGKIGL levels NGS detection during other timepoints such as the interim of induction and timepoints after NGS-MRD was negative was not mandatory but monitored as per parents preference The patients were followed up until August 30 2022 and the median follow-up time was 207 months
Statistical Analysis The association between categorical variables was tested using χ2 test the correlation between quantitative variables was measured using Pearson correlation and tested using Students t distribution and ANOVA was used to compare quantitative variables Event-free survival EFS and overall survival OS curves were estimated using the Kaplan-Meier method and compared according to the log rank test Death during induction abandonment before complete remission death in continuous complete remission relapse and secondary malignancies were considered as events in the calculation of EFS probability The EFS time was calculated from the date of diagnosis to the last date of follow-up or the first event The OS was calculated from the date of diagnosis to death from any causes with censoring the patients alive at the time of data analysis The final date for follow-up was August 30 2022 Data visualization was performed using R package ggplot2 Version 403 and GraphPad Prism 900 Statistical analysis was performed on R Version 403 A P value of 005 2 tailed was considered to be statistically significant
The European Group for the Immunological Characterization of Leukemias EGIL criteria were applied to diagnose and classify ALL in this study All enrolled patients were treated according to the ZJCH-ALL-2019 protocol detailed in the supplementary file This protocol was implemented in our center in September 2018 and subsequently extended to all of Zhejiang Province in 2019 In this protocol NGS-MRD was not used for patient risk stratification or treatment allocation For the detection of MRD bone marrow BM aspiration for Ig NGS was collected at diagnosis the end of induction EOI at the 5th week from the initial prednisone prephase and the end of consolidation EOC at the 13th week which was before the start of early intensification for low and intermediate risk patients and was before the start of the second course of consolidation for high-risk patients NGS-MRD was sequentially monitored every 2 to 3 months after consolidation until it was undetectable In this study NGS-MRD refers to the quantitative value of MRD detected through NGS testing which was the sum of IGH and light chain IGKIGL levels NGS detection during other timepoints such as the interim of induction and timepoints after NGS-MRD was negative was not mandatory but monitored as per parents preference The patients were followed up until August 30 2022 and the median follow-up time was 207 months
Statistical Analysis The association between categorical variables was tested using χ2 test the correlation between quantitative variables was measured using Pearson correlation and tested using Students t distribution and ANOVA was used to compare quantitative variables Event-free survival EFS and overall survival OS curves were estimated using the Kaplan-Meier method and compared according to the log rank test Death during induction abandonment before complete remission death in continuous complete remission relapse and secondary malignancies were considered as events in the calculation of EFS probability The EFS time was calculated from the date of diagnosis to the last date of follow-up or the first event The OS was calculated from the date of diagnosis to death from any causes with censoring the patients alive at the time of data analysis The final date for follow-up was August 30 2022 Data visualization was performed using R package ggplot2 Version 403 and GraphPad Prism 900 Statistical analysis was performed on R Version 403 A P value of 005 2 tailed was considered to be statistically significant
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None