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| Name | Class |
|---|---|
| Hangzhou Repugene Technology Co., Ltd. | UNKNOWN |
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Circulating tumor DNA (ctDNA) is a promising biomarker for noninvasive assessment of cancer burden. In this study, PEAC (Personalized Analysis of Cancer) technology was performed to detect the driver gene mutations from plasma samples and matched tumor tissue samples were detected by NGS platform at baseline. Investigators also applied ctDNA dynamic monitoring using PEAC technology in early stage NSCLC patients with driver mutations positive at baseline, to evaluate the feasibility and their potential clinical application.
Circulating tumor DNA (ctDNA) is a promising biomarker for noninvasive assessment of cancer burden. Advances in DNA sequencing technologies and our understanding of the molecular biology of tumours have resulted in increased interest in exploiting ctDNA as a tool to facilitate earlier detection of cancer and thereby improve therapeutic outcomes by enabling early intervention. In this study, PEAC (Personalized Analysis of Cancer) technology was performed to detect the driver gene mutations from plasma samples and matched tumor tissue samples were detected by NGS platform at baseline. Investigators aim to evaluate whether driver gene mutations detected by PEAC can replace tissue testing results in patients with stage I to â…¢ NSCLC. Investigators also applied ctDNA dynamic monitoring using PEAC technology in early stage NSCLC patients with driver mutations positive at baseline, to evaluate the feasibility and their potential clinical application.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Perioperative ctDNA Dynamic Monitoring Group | Samples were obtained at multiple pre-specified time points including before surgery (plasma samples),during surgery after tumor resection (tumor samples) and after surgery(plasma samples were obtained every 6 months from ctDNA positive patients at baseline in the following 2 years) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Perioperative ctDNA Dynamic Monitoring | Diagnostic Test | To apply ctDNA dynamic monitoring in early stage NSCLC patients with driver mutations positive at baseline |
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| Measure | Description | Time Frame |
|---|---|---|
| Concordance between genomic alterations assessed by next-generation sequencing in tumor tissue and PEAC technology in circulating tumor DNA | PEAC (Personalized Analysis of Cancer) technology was performed to detect the driver gene mutations from plasma samples and matched tumor tissue samples were detected by NGS platform at baseline. | 2 years after the last patient enrolled |
| ctDNA dynamic monitoring | PEAC technology was performed to apply ctDNA dynamic monitoring in early stage NSCLC patients with driver mutations positive at baseline | 2 years after the last patient enrolled |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with stage I to III Non-Small Cell Lung Cancer (NSCLC) with R0 resection
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| Name | Affiliation | Role |
|---|---|---|
| Si-Yu Wang, MD | Sun Yat-sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen University Cancer Center | Guangzhou | Guangdong | 510060 | China |
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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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Tumor Tissue, Whole Blood
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |