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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| T790M mutation test | genomic testing of T790M mutation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| genomic testing of T790M mutation | Procedure | patients will need to have genomic testing of T790M mutation at hospital laboratories and in central laboratory. |
|
| Measure | Description | Time Frame |
|---|---|---|
| the concordance of T790M mutation testing between the test in central and local labs | Concordance (%)=(number of patients with same T790M mutation status based on central and local labs)/(total number of patients in the FAS) ×100% | within 1 -14 days after enrolled |
| Measure | Description | Time Frame |
|---|---|---|
| The prevalence rate of T790M mutation based on the central lab testing | Prevalence (%) = (number of patients with T790M mutation positive)/(total number of patients in the FAS)×100% | within 1 -14 days after enrolled |
| The sensitivity of each platform based on the local lab plasma testing |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Beijing | 100021 | China | |||
| Research Site |
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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% |
| within 1 -14 days after enrolled |
| The Specificity of each platform based on the local lab plasma testing | 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% | within 1 -14 days after enrolled |
| The Positive predictive value of each platform based on the local lab plasma testing | 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% | within 1 -14 days after enrolled |
| The Negative predictive value of each platform based on the local lab plasma testing | 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% | within 1 -14 days after enrolled |
| The Concordance of each platform based on the local lab testing | Concordance (%)=(number of patients with same T790M mutation status based on tissue and plasma tests)/(total number of patients in the FAS) ×100% | within 1 -14 days after enrolled |
| 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 | Prevalence (%) = (number of patients with C797S mutation positive)/(total number of patients with evaluable C797S testing)×100% | within 1 -14 days after enrolled |
| Rare EGFR mutation prevalence rate | Prevalence (%) = (number of patients with rare EGFR mutation positive)/(total number of patients in the FAS)×100% | within 1-14 days after enrolled |
| Beijing |
| China |
| Research Site | Changchun | 130012 | China |
| Research Site | Changchun | 130021 | China |
| Research Site | Chengdu | 610041 | China |
| Research Site | Guangzhou | 510080 | China |
| Research Site | Hangzhou | 310003 | China |
| Research Site | Hangzhou | 310006 | China |
| Research Site | Hangzhou | 310009 | China |
| Research Site | Hangzhou | 310022 | China |
| Research Site | Harbin | 150049 | China |
| Research Site | Hefei | 230001 | China |
| Research Site | Hohhot | 010017 | China |
| Research Site | Jinan | 2501117 | China |
| Research Site | Kunming | 650118 | China |
| Research Site | Linhai | 317000 | China |
| Research Site | Nanchang | 330006 | China |
| Research Site | Nanjing | 210029 | China |
| Research Site | Qingdao | 266071 | China |
| Research Site | Shanghai | 200032 | China |
| Research Site | Shanghai | 200433 | China |
| Research Site | Shenyang | 110001 | China |
| Research Site | Shenzhen | 518020 | China |
| Research Site | Ürümqi | 830000 | China |
| Research Site | Ürümqi | 830054 | China |
| Research Site | Wuhan | 430022 | China |
| Research Site | Wuhan | 430030 | China |
| Research Site | Xi'an | 710061 | China |
| Research Site | Xi'an | China |
| Research Site | Yantai | 264000 | China |
| Research Site | Zhengzhou | 450008 | China |