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Trial record 35 of 181 for:    DCLRE1C

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

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ClinicalTrials.gov Identifier: NCT02991274
Recruitment Status : Completed
First Posted : December 13, 2016
Last Update Posted : June 12, 2019
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Tracking Information
First Submitted Date December 9, 2016
First Posted Date December 13, 2016
Last Update Posted Date June 12, 2019
Actual Study Start Date January 16, 2017
Actual Primary Completion Date June 29, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 5, 2017)
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%
Original Primary Outcome Measures
 (submitted: December 9, 2016)
the concordance of T790M resistance 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 cental and local labs)/(total number of patients in the FAS) ×100%
Change History Complete list of historical versions of study NCT02991274 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: June 5, 2017)
  • 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%
Original Secondary Outcome Measures
 (submitted: December 9, 2016)
  • 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 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%
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
Official Title A Study of T790M Mutation Testing in Patient Tissue and Blood With Various Detection Platforms at Hospital Laboratories in Comparison With Central Testing
Brief Summary 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.
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.
Study Type Observational
Study Design Not Provided
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Not Provided
Study Population Not Provided
Condition Locally Advanced or Metastatic EGFR(+) NSCLC Patients
Intervention Procedure: genomic testing of T790M mutation
patients will need to have genomic testing of T790M mutation at hospital laboratories and in central laboratory.
Study Groups/Cohorts T790M mutation test
genomic testing of T790M mutation
Intervention: Procedure: genomic testing of T790M mutation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: September 24, 2018)
897
Original Estimated Enrollment
 (submitted: December 9, 2016)
800
Actual Study Completion Date June 29, 2018
Actual Primary Completion Date June 29, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT02991274
Other Study ID Numbers D5160C00041
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party AstraZeneca
Study Sponsor AstraZeneca
Collaborators Not Provided
Investigators
Principal Investigator: Caicun Zhou Shanghai Pulmonary Hospital, Shanghai, China
Principal Investigator: Jie He Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Principal Investigator: Jie Wang Cancer Institute and Hospital, Chinese Academy of Medical Sciences
PRS Account AstraZeneca
Verification Date June 2019