Study identifier:D5160C00041
ClinicalTrials.gov identifier:NCT02991274
EudraCT identifier:N/A
CTIS identifier:N/A
A study of T790M mutation testing in patient tissue and blood with various detection platforms at hospital laboratories in comparison with central testing
locally advanced or metastatic EGFR(+) NSCLC patients
Phase 4
No
-
All
897
Observational
18 Years +
Allocation: N/A
Endpoint Classification: N/A
Intervention Model: Single Group Assignment
Masking: -
Primary Purpose: Diagnostic
Verified 01 Jun 2019 by AstraZeneca
AstraZeneca
-
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.
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.
Location
Location
Xi'An, China
Location
hangzhou, China, 310006
Location
Hangzhou, China, 310022
Location
Ji Nan, China, 2501117
Location
Nanjing, China, 210029
Location
Qingdao, China, 266071
Location
Hangzhou, China, 310009
Location
Hangzhou, China, 310003
Arms | Assigned Interventions |
---|---|
Other: T790M mutation test genomic testing of T790M mutation | Procedure/Surgery: genomic testing of T790M mutation patients will need to have genomic testing of T790M mutation at hospital laboratories and in central laboratory. |
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