Evaluation of a digital PCR liquid biopsy kit for detecting EGFR T790M mutations in lung cancer
Evaluation of Clinical Performance and IVD Test of LifeOS Digital PCR Liquid Biopsy Kits for EGFR T790M Mutation
LifeOS Genomics Corporation · NCT06573073
This study is testing a new blood test to see if it can accurately find a specific mutation in lung cancer patients to help guide their treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | LifeOS Genomics Corporation (industry) |
| Locations | 1 site (Taipei) |
| Trial ID | NCT06573073 on ClinicalTrials.gov |
What this trial studies
This study evaluates the clinical performance of the LifeOS Digital PCR Liquid Biopsy Kit specifically designed for detecting the EGFR T790M mutation in patients with non-small cell lung cancer (NSCLC). The approach utilizes advanced digital PCR technology, which enhances analytical sensitivity and allows for precise mutation detection. The clinical validation is being conducted by the Core Laboratory of Pharmacogenomics at National Taiwan University, focusing on patients with advanced stages of NSCLC. The study aims to assess the effectiveness of this liquid biopsy method in monitoring disease progression and informing treatment decisions.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with Stage IIIB or IV non-small cell lung cancer who have EGFR mutations.
Not a fit: Patients who are pregnant or have conditions that pose severe risks or interfere with trial results will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more accurate and less invasive method for detecting EGFR T790M mutations, leading to better personalized treatment options for lung cancer patients.
How similar studies have performed: Other studies utilizing liquid biopsy and digital PCR technologies have shown promising results, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. aged ≥18 years old. 2. Patients with Stage IIIB or IV non-small cell lung cancer (NSCLC) with EGFR mutations. Exclusion Criteria: 1. Pregnant women. 2. Any condition that, in the opinion of the doctors, may pose a severe risk to the patient or interfere with trial results or participation.
Where this trial is running
Taipei
- National Taiwan University — Taipei, Taiwan (RECRUITING)
Study contacts
- Principal investigator: Sung-Liang Yu, PhD — National Taiwan University
- Study coordinator: Sung-Liang Yu, PhD
- Email: slyu@ntu.edu.tw
- Phone: +886 23123456
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.
Conditions: Non Small Cell Lung Cancer, EGFR T790M, Liquid biopsy, digital Polymerase Chain Reaction