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 | Recruiting

• 1 other identifier: 461_2566
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Myelogenous Leukemia

Keywords

BCR-ABL p210 mRNA transcripts; Dr. PCR™ BCR-ABL1 Major IS Detection; Chronic Myelogenous Leukemia

Outcome Measures

Primary Outcomes (2)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• In adequate or poor-quality specimen

Sponsors & Collaborators

• Siriraj Hospital: lead

Study Sites (1)

Siriraj hospital

Bangkok, 10700, Thailand

RECRUITING

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

weerapat Owattanapanich, MD

CONTACT

0891081963; weerapato36733@gmail.com

Wannachai Saisaard, MT

CONTACT

0817141717; wern.si12@gmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: February 20, 2024
• First Posted: March 8, 2024
• Study Start: March 20, 2024
• Primary Completion: March 30, 2024
• Study Completion: July 30, 2024
• Last Updated: March 8, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

TH (1)