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.
Name: genomic testing of T790M mutation
Description: patients will need to have genomic testing of T790M mutation at hospital laboratories and in central laboratory.Type: ProcedureT790M mutation test
Description: Concordance (%)=(number of patients with same T790M mutation status based on central and local labs)/(total number of patients in the FAS) ×100%
Measure: the concordance of T790M mutation testing between the test in central and local labs Time: within 1 -14 days after enrolledDescription: Prevalence (%) = (number of patients with T790M mutation positive)/(total number of patients in the FAS)×100%
Measure: The prevalence rate of T790M mutation based on the central lab testing Time: within 1 -14 days after enrolledDescription: 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%
Measure: The sensitivity of each platform based on the local lab plasma testing Time: within 1 -14 days after enrolledDescription: 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%
Measure: The Specificity of each platform based on the local lab plasma testing Time: within 1 -14 days after enrolledDescription: 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%
Measure: The Positive predictive value of each platform based on the local lab plasma testing Time: within 1 -14 days after enrolledDescription: 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%
Measure: The Negative predictive value of each platform based on the local lab plasma testing Time: within 1 -14 days after enrolledDescription: Concordance (%)=(number of patients with same T790M mutation status based on tissue and plasma tests)/(total number of patients in the FAS) ×100%
Measure: The Concordance of each platform based on the local lab testing Time: within 1 -14 days after enrolledDescription: Prevalence (%) = (number of patients with C797S mutation positive)/(total number of patients with evaluable C797S testing)×100%
Measure: 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 Time: within 1 -14 days after enrolledDescription: Prevalence (%) = (number of patients with rare EGFR mutation positive)/(total number of patients in the FAS)×100%
Measure: Rare EGFR mutation prevalence rate Time: within 1-14 days after enrolledThere are 2 SNPs
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. --- C797S ---
Prevalence (%) = (number of patients with C797S mutation positive)/(total number of patients with evaluable C797S testing)×100%. --- C797S ---
Prevalence (%) = (number of patients with C797S mutation positive)/(total number of patients with evaluable C797S testing)×100%. --- C797S --- --- C797S ---
A Study of T790M Mutation Testing in Patient Tissue and Blood With Various Detection Platforms at Hospital Laboratories in Comparison With Central Testing. --- T790M ---
ARTEMIS DIANE T790M (An Amino Acid Substitution at Position 790 in EGFR, From a Threonine (T) to a Methionine (M)) Mutation at Hospital Laboratories in Comparison With Central Laboratory 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. --- T790M ---
ARTEMIS DIANE T790M (An Amino Acid Substitution at Position 790 in EGFR, From a Threonine (T) to a Methionine (M)) Mutation at Hospital Laboratories in Comparison With Central Laboratory 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. --- T790M --- --- T790M ---
ARTEMIS DIANE T790M (An Amino Acid Substitution at Position 790 in EGFR, From a Threonine (T) to a Methionine (M)) Mutation at Hospital Laboratories in Comparison With Central Laboratory 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. --- T790M --- --- T790M --- --- T790M ---
the concordance of T790M mutation testing between the test in central and local labs. --- T790M ---
Concordance (%)=(number of patients with same T790M mutation status based on central and local labs)/(total number of patients in the FAS) ×100%. --- T790M ---
The prevalence rate of T790M mutation based on the central lab testing. --- T790M ---
Prevalence (%) = (number of patients with T790M mutation positive)/(total number of patients in the FAS)×100%. --- T790M ---
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%. --- T790M ---
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%. --- T790M --- --- T790M ---
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%. --- T790M ---
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%. --- T790M --- --- T790M ---
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%. --- T790M ---
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%. --- T790M --- --- T790M ---
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%. --- T790M ---
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%. --- T790M --- --- T790M ---
Concordance (%)=(number of patients with same T790M mutation status based on tissue and plasma tests)/(total number of patients in the FAS) ×100%. --- T790M ---
800 patients from 80 different hospital sites will have local T790M testing by different molecular testing platforms and have central testing by Cobas platform. --- T790M ---
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. --- T790M ---
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. --- T790M --- --- T790M ---
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. --- T790M --- --- T790M --- --- T790M ---