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Trial Title:
Evaluation of Clinical Performance and IVD Test of LifeOS Digital PCR Liquid Biopsy Kits for EGFR T790M Mutation
NCT ID:
NCT06573073
Condition:
Non Small Cell Lung Cancer
EGFR T790M
Conditions: Official terms:
Carcinoma, Non-Small-Cell Lung
Conditions: Keywords:
Liquid biopsy
digital Polymerase Chain Reaction (PCR)
EGFR T790M
Study type:
Observational [Patient Registry]
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
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.
Criteria for eligibility:
Study pop:
Late stage NSCLC patients with EGFR activating mutations
Sampling method:
Non-Probability Sample
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
National Taiwan University
Address:
City:
Taipei
Zip:
10617
Country:
Taiwan
Status:
Recruiting
Contact:
Last name:
Sung-Liang Yu, PhD
Phone:
+886 23123456
Phone ext:
288697
Email:
slyu@ntu.edu.tw
Start date:
August 6, 2024
Completion date:
December 31, 2028
Lead sponsor:
Agency:
LifeOS Genomics Corporation
Agency class:
Industry
Collaborator:
Agency:
National Taiwan University
Agency class:
Other
Collaborator:
Agency:
National Taiwan University Hospital
Agency class:
Other
Collaborator:
Agency:
National Taiwan University Cancer Center
Agency class:
Other
Collaborator:
Agency:
Chung Shan Medical University
Agency class:
Other
Collaborator:
Agency:
Chang Gung Memorial Hospital
Agency class:
Other
Collaborator:
Agency:
Tri-Service General Hospital
Agency class:
Other
Collaborator:
Agency:
Far Eastern Memorial Hospital
Agency class:
Other
Source:
LifeOS Genomics Corporation
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06573073
