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

Recruiting

• Conditions: Chronic Myelogenous Leukemia

• Registration Number: NCT06301321
• Lead Sponsor: Siriraj Hospital

Brief Summary

Today, there are many commercial kits for detecting BCR-ABL fusion transcripts. The QXDx™ BCR-ABL %IS kit (Bio-Rad, Hercules, CA, USA) is the first ddPCR-based in vitro diagnostics (IVD) product with the US Food and Drug Administration clearance and European Conformity (CE) mark which launched in 2017. Dr. PCR™ BCR-ABL1 Major IS Detection Kit (Optolane, South Korea) is one of CE-IVD commercial kits based on digital RT-PCR. Both commercial kits are digital PCR-based, also evaluated their correlation, pros and cons in order for users to select a reagents kit that are appropriate for themselves.

Detailed Description

Today, there are many commercial kits for detecting BCR-ABL fusion transcripts. The QXDx™ BCR-ABL %IS kit (Bio-Rad, Hercules, CA, USA) is the first ddPCR-based in vitro diagnostics (IVD) product with the US Food and Drug Administration clearance and European Conformity (CE) mark which launched in 2017. Dr. PCR™ BCR-ABL1 Major IS Detection Kit (Optolane, South Korea) is one of CE-IVD commercial kits based on digital RT-PCR. Both commercial kits are digital PCR-based, also evaluated their correlation, pros and cons in order for users to select a reagents kit that are appropriate for themselves.

Objectives 1.To evaluate and comparison of BCR-ABL p210 mRNA transcripts (%IS unit) results from two detection kit ; Dr. PCR™ BCR-ABL1 Major IS Detection Kit (Optolane) VS QXDx™ BCR-ABL %IS Kit (Bio-Rad) in chronic myeloid leukemia (CML) patients Secondary objective 2.To be used as a standard inspection method of the Hematology laboratory at Siriraj Hospital Inclusion criteria

1. 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.

2. All samples were successively tested by QXDx™ BCR-ABL %IS Kit (Bio-Rad) which used Droplet Digital PCR (ddPCR) technique.

Exclusion criteria

1.In adequate or poor-quality specimen

Study Timeline

• Study First Submitted: 2024-02-20
• Status Verified: 2024-03
• Study First Submitted QC: 2024-03-03
• Last Update Submitted: 2024-03-03
• Study First Posted: 2024-03-08
• Last Update Posted: 2024-03-08
• Study Start: 2024-03-20
• Primary Completion: 2024-03-30
• Study Completion: 2024-07-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sensitivity	Through study completion, an average of 1 year	Positive predictive value, negative predictive value and AUC. A p-value \< 0.05 was considered statistically significant difference.
Specificity	Through study completion, an average of 1 year	Positive predictive value, negative predictive value and AUC. A p-value \< 0.05 was considered statistically significant difference.

Trial Locations

Locations (1)

Siriraj hospital; 🇹🇭 Bangkok, Thailand