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

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-8-11
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Inclusion Criteria:<br><br> 1. aged =18 years old.<br><br> 2. Patients with Stage IIIB or IV non-small cell lung cancer (NSCLC) with EGFR<br> mutations.<br><br>Exclusion Criteria:<br><br> 1. Pregnant women.<br><br> 2. Any condition that, in the opinion of the doctors, may pose a severe risk to the<br> patient or interfere with trial results or participation.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Observational [Patient Registry]
• 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.

Secondary Outcome Measures

Name	Time	Method
Sensitivity of the LifeOS EGFR T790M cfDNA Detection Kit relative to the cobas® EGFR Mutation Test v2.;Specificity of the LifeOS EGFR T790M cfDNA Detection Kit relative to the cobas® EGFR Mutation Test v2.