Evaluation of Clinical Performance and IVD Test of LifeOS Digital PCR Liquid Biopsy Kits for EGFR T790M Mutation

Recruiting

• Conditions: Non Small Cell Lung Cancer; EGFR T790M

• Registration Number: NCT06573073
• Lead Sponsor: LifeOS Genomics Corporation

Brief Summary

Liquid biopsy plays a pivotal role in cancer therapeutics, encompassing critical applications such as early cancer detection, disease progression monitoring, and tailored treatment plan formulation, heralded as a pivotal avenue for the future of cancer management. Established in 2015, LifeOS Genomics Co., Ltd. stands among the select few domestic enterprises pioneering the autonomous development of digital Polymerase Chain Reaction (PCR) technology. The company's automated nucleic acid amplification quantitative analysis platform (QLoci™ md1000 Analyzer) demonstrates outstanding proficiency, featuring sixty thousand wells per PCR chip. Integrating digital PCR technology, it elevates analytical sensitivity beyond 0.1%. LifeOS commissioned the Core Laboratory of Pharmacogenomics at the National Taiwan University to conduct clinical validation assessments for their developed "EGFR T790M Mutation Detection Assay Kit." This assay kit secured official registration by the Taiwan Food and Drug Administration (TFDA) as a Laboratory Developed Test (LDT) in 2023, permitting the issuance of medical testing reports.

This initiative aims to validate the detection capabilities of LifeOS Genomics Co., Ltd.'s "EGFR T790M Mutation Detection Assay Kit" prospectively clinically in clinical lung cancer patient plasma samples, addressing unmet clinical needs for early cancer detection, disease progression monitoring, and aiding physicians in diagnosis and pharmacotherapy.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-08
• Study First Submitted: 2024-08-11
• Study First Submitted QC: 2024-08-25
• Study First Posted: 2024-08-27
• Study Start: 2024-09-06
• Last Update Submitted: 2024-11-14
• Last Update Posted: 2024-11-18
• Primary Completion: 2026-12-31
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Concordance in detecting EGFR T790M using the LifeOS EGFR T790M cfDNA Detection Kit and the cobas® EGFR Mutation Test v2.	5 years	The primary endpoint is to assess the concordance between the LifeOS EGFR T790M cfDNA Detection Kit and the cobas® EGFR Mutation Test v2 in detecting the presence of EGFR T790M in cfDNA from plasma.

Secondary Outcome Measures

Name	Time	Method
Sensitivity of the LifeOS EGFR T790M cfDNA Detection Kit relative to the cobas® EGFR Mutation Test v2.	5 years	The secondary endpoint is to assess the sensitivity between the LifeOS EGFR T790M cfDNA Detection Kit and the cobas® EGFR Mutation Test v2 in detecting the presence of EGFR T790M in cfDNA from plasma.
Specificity of the LifeOS EGFR T790M cfDNA Detection Kit relative to the cobas® EGFR Mutation Test v2.	5 years	The secondary endpoint is to assess the specificity between the LifeOS EGFR T790M cfDNA Detection Kit and the cobas® EGFR Mutation Test v2 in detecting the presence of EGFR T790M in cfDNA from plasma.

Trial Locations

Locations (1)

National Taiwan University; 🇨🇳 Taipei, Taiwan