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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

NCT06301321 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 80

Last updated 2024-03-08

No results posted yet for this study

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.

Conditions

  • Chronic Myelogenous Leukemia

Sponsors & Collaborators

  • Siriraj Hospital

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-20
Primary Completion
2024-03-30
Completion
2024-07-30

Countries

  • Thailand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06301321 on ClinicalTrials.gov