The study primary objective is to assess the concordance of T790M resistance mutation testing from hospital-based laboratories with T790M resistance mutation testing from a central laboratory.
This is a multi-center testing study. 800 patients from 80 different hospital sites will have local T790M testing by different molecular testing platforms and have central testing by Cobas platform. These two sets of data (local T790M testing and central T790M testing) will be analysed and compared to assess the concordance of these T790M testing platforms.
Study Type
OBSERVATIONAL
Enrollment
897
patients will need to have genomic testing of T790M mutation at hospital laboratories and in central laboratory.
Research Site
Beijing, China
the concordance of T790M mutation testing between the test in central and local labs
Concordance (%)=(number of patients with same T790M mutation status based on central and local labs)/(total number of patients in the FAS) ×100%
Time frame: within 1 -14 days after enrolled
The prevalence rate of T790M mutation based on the central lab testing
Prevalence (%) = (number of patients with T790M mutation positive)/(total number of patients in the FAS)×100%
Time frame: within 1 -14 days after enrolled
The sensitivity of each platform based on the local lab plasma testing
Sensitivity (%)=(number of patients with T790M mutation positive based on both tissue and plasma tests)/(number of patients with T790M mutation positive based on tissue test) ×100%
Time frame: within 1 -14 days after enrolled
The Specificity of each platform based on the local lab plasma testing
Specificity (%)=(number of patients with T790M mutation negative based on both tissue and plasma tests)/(number of patients with T790M mutation negative based on tissue test) ×100%
Time frame: within 1 -14 days after enrolled
The Positive predictive value of each platform based on the local lab plasma testing
Positive predictive value (%)=(number of patients with T790M mutation positive based on both tissue and plasma tests)/(number of patients with T790M mutation positive based on plasma test) ×100%
Time frame: within 1 -14 days after enrolled
The Negative predictive value of each platform based on the local lab plasma testing
Negative predictive value (%)=(number of patients with T790M mutation negative based on both tissue and plasma tests)/(number of patients with T790M mutation negative based on plasma test) ×100%
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Research Site
Beijing, China
Research Site
Changchun, China
Research Site
Changchun, China
Research Site
Chengdu, China
Research Site
Guangzhou, China
Research Site
Hangzhou, China
Research Site
Hangzhou, China
Research Site
Hangzhou, China
Research Site
Hangzhou, China
...and 21 more locations
Time frame: within 1 -14 days after enrolled
The Concordance of each platform based on the local lab testing
Concordance (%)=(number of patients with same T790M mutation status based on tissue and plasma tests)/(total number of patients in the FAS) ×100%
Time frame: within 1 -14 days after enrolled
The prevalence of C797S (An amino acid substitution at position 797 in EGFR, from a Cysteine (C) to a Serine (S) ) resistance mutation based on the local lab testing
Prevalence (%) = (number of patients with C797S mutation positive)/(total number of patients with evaluable C797S testing)×100%
Time frame: within 1 -14 days after enrolled
Rare EGFR mutation prevalence rate
Prevalence (%) = (number of patients with rare EGFR mutation positive)/(total number of patients in the FAS)×100%
Time frame: within 1-14 days after enrolled