Evaluation of Clinical Performance and IVD Test of LifeOS Digital PCR Liquid Biopsy Kits for EGFR T790M Mutation
NCT Number: NCT06573073
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Non Small Cell Lung Cancer|EGFR T790M
Sponsor: LifeOS Genomics Corporation
Collaborators: National Taiwan University|National Taiwan University Hospital|National Taiwan University Cancer Center|Chung Shan Medical University|Chang Gung Memorial Hospital|Tri-Service General Hospital|Far Eastern Memorial Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 300
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-06
Completion Date: 2028-12-31
Locations: National Taiwan University, Taipei, 10617, Taiwan

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.

Primary Outcome Measures: Concordance in detecting EGFR T790M using the LifeOS EGFR T790M cfDNA Detection Kit and the cobas® EGFR Mutation Test v2., 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., 5 years
Secondary Outcome Measures: Sensitivity of the LifeOS EGFR T790M cfDNA Detection Kit relative to the cobas® EGFR Mutation Test v2., 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., 5 years|Specificity of the LifeOS EGFR T790M cfDNA Detection Kit relative to the cobas® EGFR Mutation Test v2., 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., 5 years