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 (BCR-ABL1)

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Myelogenous Leukemia

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 Type: Observational
• Enrollment (Estimated): 80

Contacts and Locations

• Study Contact: Name: weerapat Owattanapanich, MD; Phone Number: 0891081963; Email: weerapato36733@gmail.com
• Study Contact Backup: Name: Wannachai Saisaard, MT; Phone Number: 0817141717; Email: wern.si12@gmail.com

Study Locations

• Thailand
  • Bangkok, Thailand, 10700
    • Recruiting
    • Siriraj Hospital
    • Contact: weerapat Owattanapanich, MD; Phone Number: 0891081963; Email: weerapato36733@gmail.com
    • Contact: Wananchi Saisaard, MT; Phone Number: 0817141717; Email: wern.si12@gmail.com
    • Principal Investigator: weerapat Owattanapanich, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

The patients 18 years and older who were newly diagnosis and known to have CML

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Siriraj Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): March 20, 2024
• Primary Completion (Estimated): March 30, 2024
• Study Completion (Estimated): July 30, 2024

Study Registration Dates

• First Submitted: February 20, 2024
• First Submitted That Met QC Criteria: March 3, 2024
• First Posted (Actual): March 8, 2024

Study Record Updates

• Last Update Posted (Actual): March 8, 2024
• Last Update Submitted That Met QC Criteria: March 3, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Chronic Myelogenous Leukemia; BCR-ABL p210 mRNA transcripts; Dr. PCR™ BCR-ABL1 Major IS Detection
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Histologic Type; Neoplasms; Disease Attributes; Bone Marrow Diseases; Hematologic Diseases; Myeloproliferative Disorders; Chronic Disease; Leukemia; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Other Study ID Numbers: 461_2566

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: IPD are available from the corresponding author on reasonable request.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No