Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06525116
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-07-24
Brief Title:
MRD Detection by NGS in Pediatric T-ALL
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Measurable Residual Disease Detection by Next-generation Sequencing of T Cell Receptor Gene Rearrangements in Pediatric T-cell Acute Lymphocytic Leukemia
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
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 T 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 T cell receptor TCR 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:
This was a prospective single-center observational study conducted in children with ALL between February 2018 and December 2022 Children with newly diagnosed T-ALL who undergone NGS of T-cell receptors at Childrens HospitalZhejiang 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 NGS was collected at diagnosis Multiple consecutive MRD test evaluation points TP were set up including but not limited to at least day 15 of induction remission the end of induction remission EOI the end of consolidation therapy EOC 6 months after diagnosis 6-month NGS-MRD was sequentially monitored every 3 to 6 months after EOC 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 TRBTRG levels The patients were followed up until June 30 2024 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 Data visualization was performed using R package ggplot2 Version 403 and GraphPad Prism 800 Statistical analysis was performed on R Version 403 A P value 005 two tailed was considered to be statistically significant
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None