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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06301321
Other study ID # 461_2566
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 20, 2024
Est. completion date July 30, 2024

Study information

Verified date March 2024
Source Siriraj Hospital
Contact weerapat Owattanapanich, MD
Phone 0891081963
Email weerapato36733@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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


Recruitment information / eligibility

Status Recruiting
Enrollment 80
Est. completion date July 30, 2024
Est. primary completion date March 30, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Locations

Country Name City State
Thailand Siriraj hospital Bangkok

Sponsors (1)

Lead Sponsor Collaborator
Siriraj Hospital

Country where clinical trial is conducted

Thailand, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
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