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

Overview

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.

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

Study Type

  • Study Type: Observational
  • Study Primary Completion Date: June 29, 2018

Detailed Description

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.

Interventions

  • Procedure: genomic testing of T790M mutation
    • patients will need to have genomic testing of T790M mutation at hospital laboratories and in central laboratory.

Arms, Groups and Cohorts

  • T790M mutation test
    • genomic testing of T790M mutation

Clinical Trial Outcome Measures

Primary Measures

  • the concordance of T790M mutation testing between the test in central and local labs
    • Time Frame: within 1 -14 days after enrolled
    • Concordance (%)=(number of patients with same T790M mutation status based on central and local labs)/(total number of patients in the FAS) ×100%

Secondary Measures

  • The prevalence rate of T790M mutation based on the central lab testing
    • Time Frame: within 1 -14 days after enrolled
    • Prevalence (%) = (number of patients with T790M mutation positive)/(total number of patients in the FAS)×100%
  • The sensitivity of each platform based on the local lab plasma testing
    • Time Frame: within 1 -14 days after enrolled
    • 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%
  • The Specificity of each platform based on the local lab plasma testing
    • Time Frame: within 1 -14 days after enrolled
    • 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%
  • The Positive predictive value of each platform based on the local lab plasma testing
    • Time Frame: within 1 -14 days after enrolled
    • 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%
  • The Negative predictive value of each platform based on the local lab plasma testing
    • Time Frame: within 1 -14 days after enrolled
    • 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%
  • The Concordance of each platform based on the local lab testing
    • Time Frame: within 1 -14 days after enrolled
    • Concordance (%)=(number of patients with same T790M mutation status based on tissue and plasma tests)/(total number of patients in the FAS) ×100%
  • 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 Frame: within 1 -14 days after enrolled
    • Prevalence (%) = (number of patients with C797S mutation positive)/(total number of patients with evaluable C797S testing)×100%
  • Rare EGFR mutation prevalence rate
    • Time Frame: within 1-14 days after enrolled
    • Prevalence (%) = (number of patients with rare EGFR mutation positive)/(total number of patients in the FAS)×100%

Participating in This Clinical Trial

Inclusion Criteria

1. Provision of informed consent or EC approve informed consent waiver prior to any study specific procedures 2. Histological or cytological confirmed locally advanced NSCLC (stage IIIB) or metastatic (stage IV) NSCLC, not amenable to curative surgery or radiotherapy. 3. Patients who have progressed following prior therapy with an EGFR-TKI agent. 4. Patients who consent to provide tumour tissue and/or blood. Exclusion Criteria:

1. Patients who disagree to participate this study. 2. Patients whose medical objection was recorded to use the existing data from medical practice for scientific research.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • AstraZeneca
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Caicun Zhou, Principal Investigator, Shanghai Pulmonary Hospital, Shanghai, China
    • Jie He, Principal Investigator, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
    • Jie Wang, Principal Investigator, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.