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Completed

NCT Number: NCT02991274

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.

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Key information

Conditions

Locally Advanced or Metastatic EGFR(+) NSCLC Patients

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Beijing, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

genomic testing of T790M mutation

Procedure

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

Primary outcomes

  1. 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 outcomes

  1. 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%

  2. 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%

  3. 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%

  4. 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%

  5. 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%

  6. 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%

  7. 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%

  8. 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%

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Dec 13, 2016
Registry last updated
Jun 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.