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Trial record 35 of 179 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

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.

Condition or disease Intervention/treatment
Locally Advanced or Metastatic EGFR(+) NSCLC Patients Procedure: genomic testing of T790M mutation

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.

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Study Type : Observational
Actual Enrollment : 897 participants
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
Actual Study Start Date : January 16, 2017
Actual Primary Completion Date : June 29, 2018
Actual Study Completion Date : June 29, 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
T790M mutation test
genomic testing of T790M mutation
Procedure: genomic testing of T790M mutation
patients will need to have genomic testing of T790M mutation at hospital laboratories and in central laboratory.




Primary Outcome Measures :
  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 Outcome Measures :
  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%



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02991274


Locations
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China
Research Site
Beijing, China, 100021
Research Site
Beijing, China
Research Site
Changchun, China, 130012
Research Site
Changchun, China, 130021
Research Site
Chengdu, China, 610041
Research Site
Guangzhou, China, 510080
Research Site
Hangzhou, China, 310003
Research Site
Hangzhou, China, 310006
Research Site
Hangzhou, China, 310009
Research Site
Hangzhou, China, 310022
Research Site
Harbin, China, 150049
Research Site
Hefei, China, 230001
Research Site
Hohhot, China, 010017
Research Site
Ji Nan, China, 2501117
Research Site
Kunming, China, 650118
Research Site
Linhai, China, 317000
Research Site
Nanchang, China, 330006
Research Site
Nanjing, China, 210029
Research Site
Qingdao, China, 266071
Research Site
Shanghai, China, 200032
Research Site
Shanghai, China, 200433
Research Site
Shenyang, China, 110001
Research Site
Shenzhen, China, 518020
Research Site
Urumqi, China, 830054
Research Site
Wuhan, China, 430022
Research Site
Wuhan, China, 430030
Research Site
Xi'an, China, 710061
Research Site
Xi'An, China
Research Site
Yantai, China, 264000
Research Site
Zhengzhou, China, 450008
Research Site
Ürümqi, China, 830000
Sponsors and Collaborators
AstraZeneca
Investigators
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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

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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT02991274     History of Changes
Other Study ID Numbers: D5160C00041
First Posted: December 13, 2016    Key Record Dates
Last Update Posted: June 12, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by AstraZeneca:
T790M
EGFR (Epidermal Growth Factor Receptor) mutation
NSCLC