Comparison of two kits for detecting BCR-ABL transcripts in chronic myeloid leukemia
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
This study is testing two different kits to see which one works better for detecting a specific gene change in people with chronic myeloid leukemia.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Siriraj Hospital Academic / other |
| Locations | 1 site (Bangkok) |
| Trial ID | NCT06301321 on ClinicalTrials.gov |
What this trial studies
This study evaluates and compares the results of BCR-ABL p210 mRNA transcripts using two different detection kits: Dr. PCR™ BCR-ABL1 Major IS Detection Kit and QXDx™ BCR-ABL %IS Kit. Both kits utilize digital PCR technology to assess the presence of BCR-ABL fusion transcripts in chronic myeloid leukemia (CML) patients. The study aims to determine the correlation, advantages, and disadvantages of each kit to help clinicians choose the most appropriate testing method. It involves analyzing leftover RNA samples from CML patients who have undergone treatment or are newly diagnosed.
Who should consider this trial
Good fit: Ideal candidates for this study are chronic myeloid leukemia patients with leftover RNA samples after treatment or newly diagnosed.
Not a fit: Patients with inadequate or poor-quality specimens will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help standardize the detection of BCR-ABL transcripts, leading to improved monitoring and treatment decisions for CML patients.
How similar studies have performed: Other studies have shown success in using digital PCR methods for detecting BCR-ABL transcripts, indicating that this approach is validated.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Bangkok
- Siriraj hospital — Bangkok, Thailand (Recruiting)
Study contacts
- Study coordinator: weerapat Owattanapanich, MD
- Email: weerapato36733@gmail.com
- Phone: 0891081963
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.