MRD Detection by NGS in Pediatric T-ALL

NCT06525116 | Completed

• 1 other identifier: 2024-IRB-0210-P-01
• Study Type: observational
• Target: 69
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Lymphoblastic Leukemia, Pediatric

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 February 2018 and December 2022

Interventions

MRD OTHER

Calculate the 3-year EFS based on the MRD status (MRD positive and negative groups)

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Children under the age of 18 years diagnosed with acute T-cell lymphoblastic leukemia between 2018 and 2022

You may qualify if:

• Children with newly diagnosed T-ALL who undergone NGS of T-cell receptors

You may not qualify if:

• T-ALL patients who have not undergone high-throughput sequencing.
• T-ALL Patients without traceable significant clones.

Sponsors & Collaborators

• The Children's Hospital of Zhejiang University School of Medicine: lead

Study Sites (1)

The Children's Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310003, China

Location

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

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 24, 2024
• First Posted: July 29, 2024
• Study Start: February 1, 2018
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: July 29, 2024

Record last verified: 2024-07

Locations

CN (1)