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Liquid biopsy is emerging as an essential tool in tumor monitoring and a potential alternative and supplement to tissue biopsy for tumor genotyping, especially in relapsed or metastatic diseases. Liquid biopsy methods for detecting T790M in ctDNA can be qualitative or quantitative, including amplification refractory mutation system PCR (ARMS-PCR), digital droplet polymerase chain reaction (ddPCR), and next generation sequencing (NGS)-based methods. Comparison of multiple detecting platform for EGFR mutations in plasma samples has been undertaken in studies to determine the most feasible assay in clinical practice. In this study, we will investigate the usefulness of ddPCR for quantitative detection of EGFR T790M mutation in peripheral blood, and compared the utility of ddPCR and NGS for guiding decisions regarding osimertinib therapy in NSCLC patients who had develop resistance to first- or second generation EGFR-TKIs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Osimertinib | Experimental | Osimertinib 80mg po daily |
|
| Other treatments | Sham Comparator | chemotherapy or continuation of TKI monotherapy or in combination of anti-angiogenic agents |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Osimertinib | Drug | Osimertinib or chemotherapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| PFS | Time from initiation of osimertinib or other anti-tumor treatment to progression or death from any cause | up to 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| ORR | the sum of CR and PR rates | up to 1 year |
| DCR | the sum of CR ,PR and SD rates | up to 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Junling Li, Professor | Contact | +8613801178891 | lijunling@cicams.ac.cn | |
| Ziyi Xu | Contact | +8618813101866 | mandarin-51@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Junling Li, Professor | Chinese Academy of Medical Sciences and Peking Union Medical College | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Junling Li | Recruiting | Beijing | Beijing Municipality | 100021 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38526910 | Derived | Xu Z, Li Y, Wang L, Hao X, Ying J, Li J, Xing P. Efficacy of third-generation epidermal growth factor receptor-tyrosine kinase inhibitors in advanced NSCLC with different T790M statuses tested via digital droplet polymerase chain reaction ddPCR and next-generation sequencing. Expert Rev Anticancer Ther. 2024 Mar-Apr;24(3-4):183-192. doi: 10.1080/14737140.2024.2334807. Epub 2024 Apr 17. |
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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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| ID | Term |
|---|---|
| C000596361 | osimertinib |
| D017239 | Paclitaxel |
| D016190 | Carboplatin |
| D000068437 | Pemetrexed |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
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| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D056831 | Coordination Complexes |
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D005971 | Glutamates |
| D024342 | Amino Acids, Acidic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000600 | Amino Acids, Dicarboxylic |