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This study aims to evaluate the use of Next Generation Sequencing (NGS) to detect circulating tumor DNA in gastric cancer patients after gastrectomy
Gastric cancer is the fourth most common cancer in Vietnam with high mortality rate. Patients at early stages undergo radical gastrectomy with curative intent, but the remaining tumor cells, termed as minimal residual disease (MRD), can later cause relapse. Conventional methods to monitor MRD such as imaging and blood tests for biomarkers such as CEA are not sensitive and specific enough. ctDNA has recently emerged as a promising noninvasive marker with high accuracy to monitor MRD and detect relapse in many cancers such as breast and colorectal cancers. However, its application in gastric cancer has not been extensively evaluated. Therefore, this study aims to use advanced NGS technologies to detect ctDNA in liquid biopsy as a biomarker to monitor MRD after radical gastrectomy.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ctDNA | Diagnostic Test | The blood samples for ctDNA and other tumor markers will be first collected within 14 days before surgery, and then be tested after gastrectomy in scheduled interval |
| Measure | Description | Time Frame |
|---|---|---|
| The sensitivity of MRD detection using ctDNA as the biomarker | The percentage of positive ctDNA detection among participants who experience disease recurrence or metastasis | 2 years after surgery |
| The specificity of MRD detection using ctDNA as the biomarker | The percentage of positive ctDNA detection among participants who do not experience disease recurrence or metastasis | 2 years after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Leading time between ctDNA detection and cancer recurrence detected by conventional methods | Time is measured between first positive ctDNA detection and first cancer recurrence detected by conventional methods | 2 years after surgery |
| Mean ctDNA level (MTM/ml) of gastric cancer before operation |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with newly diagnosed and untreated gastric adenocarcinoma
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Center Ho Chi Minh City | Ho Chi Minh City | 700000 | Vietnam |
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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The mean ctDNA level in gastric cancer patients before operation |
| Within 14 days before operation |
| Mutation profile of gastric cancer | Profiling of the most frequent gene mutations | Within 14 days before operation |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |