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The purpose of this study is to compare the frequency and abundance of T790M mutation among the different Clinical modes of EGFR-TKI failure.
An observational, non-interventional, multi-central study of comparison of the frequency and abundance of T790M mutation using both amplification refractory mutation system (ARMS) and digital droplet PCR (ddPCR) methods among the different Clinical modes of non-small cell lung cancer (NSCLC) patients with epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) failure
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mutation detection | Other | |||
| ARMS and ddPCR | Other | |||
| ctDNA analysis | Genetic |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With T790M Mutation Detected by Amplification Refractory Mutation System (ARMS) Assay | The investigators will describe the number of T790M mutation on ctDNA detected by ARMS assay in patients with non-small cell lung cancer (NSCLC) resistant to tyrosine kinase inhibitors (TKIs). | up to 2 years |
| Abundance of T790M Mutation Detected by Digital Droplet PCR (ddPCR) Assay in Each Individual Patient | The investigators will describe the abundance of T790M mutation on ctDNA detected by ddPCR assay in patients with NSCLC resistant to TKIs. | up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Number of T790M Mutation by ARMS and ddPCR Assays in Each Different Clinical Modes of TKI Failure | The investigators will describe the number of participants with T790M mutation in each different clinical mode of TKI failure by ARMS and ddPCR, and employ chi-square test to analyze the distribution of T790M mutation by ARMS and ddPCR in patients among the different Clinical modes of TKI failure. | up to 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with Non small cell lung cancer (NSCLC) after EGFR-TKI failure
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hangzhou First People's Hospital | Hangzhou | Zhejiang | 310006 | China |
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| ID | Title | Description |
|---|---|---|
| FG000 | TKI-PD | Patients with advanced or recurrent NSCLC who had progressed during EGFR-TKIs treatment |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | TKI-PD | Patients with advanced or recurrent NSCLC patients had progressed during EGFR-TKIs treatment |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Patients With T790M Mutation Detected by Amplification Refractory Mutation System (ARMS) Assay | The investigators will describe the number of T790M mutation on ctDNA detected by ARMS assay in patients with non-small cell lung cancer (NSCLC) resistant to tyrosine kinase inhibitors (TKIs). | Posted | Number | participants | up to 2 years |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | TKI-PD | Patients with advanced or recurrent NSCLC patients had progressed during EGFR-TKIs treatment. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Shenglin Ma | Hangzhou first people's hospital | 086057156007664 | mashenglin@medmail.com.cn |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| Differences of T790M Mutation by ddPCR Among the Different Clinical Modes of TKI Failure | The investigators will employ Analysis of Variance (ANOVA) method to analyze the differences of T790M mutation by ddPCR in patients among the different Clinical modes of TKI failure. | up to 2 years |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Stage | Each patient was staged according to NCCN guidelines (2015. v6) at the time of enrollment. Generally, Stage IV showed worse prognosis. | Number | participants |
|
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| Primary | Abundance of T790M Mutation Detected by Digital Droplet PCR (ddPCR) Assay in Each Individual Patient | The investigators will describe the abundance of T790M mutation on ctDNA detected by ddPCR assay in patients with NSCLC resistant to TKIs. | Posted | Median | Full Range | percentage of total ctDNA | up to 2 years |
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| Secondary | Number of T790M Mutation by ARMS and ddPCR Assays in Each Different Clinical Modes of TKI Failure | The investigators will describe the number of participants with T790M mutation in each different clinical mode of TKI failure by ARMS and ddPCR, and employ chi-square test to analyze the distribution of T790M mutation by ARMS and ddPCR in patients among the different Clinical modes of TKI failure. | Posted | Number | participants | up to 2 years |
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| Secondary | Differences of T790M Mutation by ddPCR Among the Different Clinical Modes of TKI Failure | The investigators will employ Analysis of Variance (ANOVA) method to analyze the differences of T790M mutation by ddPCR in patients among the different Clinical modes of TKI failure. | Posted | Median | Full Range | percentage of total ctDNA | up to 2 years |
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| 0 |
| 314 |
| 0 |
| 314 |
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| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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