The Evaluation and Comparison of BCR-ABL p210 mRNA Transcripts (%IS Unit) Results Between Dr. PCR™ BCR-ABL1 Major IS Detection Kit (Optolane) and QXDx™ BCR-ABL %IS Kit (Bio-Rad) in Chronic Myeloid Leukemia Patients

Launched by SIRIRAJ HOSPITAL · Mar 3, 2024

Keywords

ClinConnect Summary

This clinical trial is studying two different testing kits used to measure a specific genetic marker (BCR-ABL p210 mRNA transcripts) in patients with Chronic Myelogenous Leukemia (CML). The goal is to compare how well these two kits, the Dr. PCR™ BCR-ABL1 Major IS Detection Kit from Optolane and the QXDx™ BCR-ABL %IS Kit from Bio-Rad, perform in detecting this marker. This information can help doctors choose the best testing method for their patients.

To participate in the trial, patients should have leftover RNA samples from their CML treatment, whether they are newly diagnosed or have been receiving treatment with Tyrosine Kinase Inhibitors (TKIs) and have regular follow-ups. However, samples must be of good quality, so those with poor or inadequate specimens cannot participate. If you join this trial, your sample will be tested with both kits to see how they compare, which may help improve future testing for CML.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Leftover RNA samples from CML patients were recruited from the Hematology Laboratory Division of Hematology Department of Medicine Faculty of Medicine, Siriraj Hospital Mahidol University, after TKI treatment and regular follow-ups or newly diagnosed.
• • All samples were successively tested by QXDx BCR-ABL %IS Kit (Bio-Rad) which used Droplet Digital PCR (ddPCR) technique.
• Exclusion Criteria:
• • In adequate or poor-quality specimen