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The aim of this study is to develop a protocol for detection of circulating tumor DNA (ctDNA) in plasma of patients with early stages of gastric cancer.
Gastric cancer (GC) is the fifth most common cancer worldwide and the third leading cause of cancer deaths. Earlier detection of GC can dramatically increases the five-year survival rate up to > 90%. The current endoscopy and tissue biopsy remain excessively expensive for middle-income nations, in addition to being fairly invasive, with possible complications. Additionally, most of serum-based biomarkers such as carcinoembryonic antigen (CEA), carbohydrate antigen 19-9 (CA19-9), carbohydrate antigen 72-4 (CA72-4), and carbohydrate antigen 125 (CA125) are not recommended for detection of GC due to the limit of specificity and sensitivity in the early stages of GC. Thus, it is essential to identify new biomarkers for diagnosis of early stages of GC. In this study, the investigators develop an ultradeep massive parallel sequencing (MPS) assay to detect tumor derived mutations (TDM) in plasma of early stages of GC. This study provides proof-of-principle for eventual clinical employment of circulating DNA, via liquid biopsy, for detection of early stages of GC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 100 healthy people | 10 ml blood and tissue biopsy were collected from each patient |
| |
| 100 gastric cancer patients | 10 ml blood and tissue biopsy were collected from each patient |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| plasma circulating tumor DNA | Diagnostic Test | A liquid biopsy assay for identification of tumor derived mutations in plasma of gastric cancer |
|
| Measure | Description | Time Frame |
|---|---|---|
| The sensitivity and and specificity of our mutation-based assay for detecting early-stage gastric cancer patients | sensitivity and and specificity of our mutation-based assay for detecting early-stage gastric cancer patients | 1 months after collecting blood and specimen |
| Measure | Description | Time Frame |
|---|---|---|
| Limit of detection (LOD): the lowest variant allelic frequency that can be reliably detected | the lowest variant allelic frequency that can be reliably detected | 1 months after collecting blood and specimen |
| The concordance rate of mutation results between plasma and tissue biopsy assay |
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Inclusion Criteria:
Exclusion Criteria:
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Patients diagnosed with early and locally advanced stage (I, II and IIIA) gastric cancer
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Long D. Vo, MD. | Contact | +84918133915 | long.vd@umc.edu.vn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Center Ho Chi Minh City | Recruiting | 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 concordance rate of mutation results between plasma and tissue biopsy |
| 1 months after collecting blood and specimen |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |