Ignite Creation Date:
2024-05-06 @ 4:24 PM
Last Modification Date:
2024-10-26 @ 2:09 PM
Study NCT ID:
NCT04977895
Status:
RECRUITING
Last Update Posted:
2021-07-27
First Post:
2021-07-11
Brief Title:
Monitoring Minimal Residual DiseaseMRDin Pediatric B-acute Lymphoblastic Leukemia
Sponsor:
Sun Yat-sen University
Organization:
Sun Yat-sen University
Study Overview
Official Title:
A Study to Assess Minimal Residual Disease by Next-generation Sequencing of Immunoglobulin Gene Rearrangements in Pediatric B-acute Lymphoblastic Leukemia
Status:
RECRUITING
Status Verified Date:
2021-07
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 study aimed to investigate the performance of next-generation sequencing NGS techniques measuring immunoglobulin heavy chain IgH-variable diversity and joining VDJ clonal rearrangements IgH-VDJ NGS compared with flow cytometry FCM in detecting of minimal residual disease MRD for children with acute lymphoblastic leukemia treated with South Chinese Children Leukemia Group SCCLG-ALL 2016 and to predict the relapse of the disease in the early stage and to assess the prognosis so as to provide the basis for early intervention treatment and reduce the hematological relapse and improve the survival rate
Detailed Description:
The measurement of residual leukemia levels minimal residual disease MRD during therapy has now emerged as the most important predictor the outcome in acute lymphoblastic leukemia ALL As a result risk-classifications based on MRD assessment has become an essential part of determining disease risk and directing therapeutic approach for children and adults with ALL
Recently next-generation sequencing NGS techniques measuring immunoglobulin Ig or T-cell receptor TCR clonal rearrangements as a method of detecting MRD have been introduced These approaches expand the sensitivity of MRD detection to as high as 1 in 10000000 cells and have been shown to be predictive of relapse in children with ALL receiving standard chemotherapy
In this study the investigators will determine the sensitivity and specificity of IgH-VDJ NGS and compared its capacity to measure MRD with that of flow cytometry using diagnostic and follow-up samples from more than 100 patients with ALL Patients under age of 18 years with newly diagnosed ALL will be recruited and receive the treatment strategy of SCCLG-ALL 2016 After identifying a trackable clone in diagnostic samples Baseline MRD was measured using IgH-VDJ NGS and FCM on bone marrow at 3 time-points fifteen days after induction therapy D15 thirty-three days after induction therapy D33 and then at the end of induction therapy Event-free survival EFS Relapse-free survival RFS and overall survival OS were assessed
Recently next-generation sequencing NGS techniques measuring immunoglobulin Ig or T-cell receptor TCR clonal rearrangements as a method of detecting MRD have been introduced These approaches expand the sensitivity of MRD detection to as high as 1 in 10000000 cells and have been shown to be predictive of relapse in children with ALL receiving standard chemotherapy
In this study the investigators will determine the sensitivity and specificity of IgH-VDJ NGS and compared its capacity to measure MRD with that of flow cytometry using diagnostic and follow-up samples from more than 100 patients with ALL Patients under age of 18 years with newly diagnosed ALL will be recruited and receive the treatment strategy of SCCLG-ALL 2016 After identifying a trackable clone in diagnostic samples Baseline MRD was measured using IgH-VDJ NGS and FCM on bone marrow at 3 time-points fifteen days after induction therapy D15 thirty-three days after induction therapy D33 and then at the end of induction therapy Event-free survival EFS Relapse-free survival RFS and overall survival OS were assessed
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