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Report for Clinical Trial NCT02991274

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Study of T790M Mutation Testing in Patient Tissue and Blood With Various Detection Platforms at Hospital Laboratories in Comparison With Central Testing

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.

NCT02991274 Locally Advanced or Me Locally Advanced or Metastatic EGFR(+) NSCLC Patients

1 Interventions

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: Procedure

T790M mutation test


Primary Outcomes

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 enrolled

Secondary Outcomes

Description: 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 enrolled

Description: 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 enrolled

Description: 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 enrolled

Description: 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 enrolled

Description: 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 enrolled

Description: 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 enrolled

Description: 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 enrolled

Description: 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 enrolled

There are 2 SNPs

SNPs


1 C797S

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 ---


2 T790M

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 ---



HPO Nodes