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| Name | Class |
|---|---|
| Fudan University | OTHER |
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This study is to determine the performance of non-invasive new multi-target biomarkers in the early detection and post-operative monitoring of gastric cancer.
This study aims to develop and validate a new non-invasive detection method for early detection and postoperative monitoring of gastric cancer in the blood. Sensitivity, specificity, accuracy, ROC curve area, positive predictive value, and negative predictive value of the new biomarkers in the diagnosis of gastric cancer will be compared with that of tumor biomarkers CA19-9, CEA, and CA72-4. Blood will also be collected at various time points post-operatively. The investigators will determine whether these new biomarkers can be used as prognostic biomarkers to predict tumor recurrence and metastasis. The investigators will also determine whether these new biomarkers detect tumor recurrence and metastasis earlier than methods currently used in the clinic such as imaging and tumor biomarkers CA19-9, CEA, and CA72-4.
This study is a prospective and multi-center study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| malignant group | Subjects diagnosed with gastric cancer. |
| |
| non-malignant group | Healthy individuals and subjects with gastritis, gastric ulcer, gastric polyp or other benign gastric diseases. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DNA test | Diagnostic Test | circulating DNA test |
|
| Measure | Description | Time Frame |
|---|---|---|
| The performance of the new detection system for gastric cancer (GC) detection | Evaluate sensitivity, specificity, accuracy, ROC curve area, positive predictive value, and negative predictive value of the new biomarker for the diagnosis of gastric cancer. | 2 years |
| The performance of the new biomarkers in the post-operative monitoring of gastric cancer | Determine whether the new detection system can detect tumor recurrence and metastasis earlier than imaging and tumor marker CA19-9, CEA, and CA72-4. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Compare the performance of the new biomarkers for GC detection with the conventional tumor markers | Determine whether the performance of the new biomarker detection system is better than that of tumor markers CA19-9, CEA, and CA72-4 in the diagnosis of gastric cancer. | 2 years |
| The performance of the new biomarkers as prognostic biomarkers |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects age over 18, regardless of gender or region, and those who meet the inclusion criteria for this clinical trial, are eligible to enroll at the designated clinical sites. More than 1197subjects are targeted to enroll.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University Shanghai Cancer Center. | Recruiting | Shanghai | Shanghai Municipality | 200032 | China |
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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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| ID | Term |
|---|---|
| D061809 | Human Papillomavirus DNA Tests |
| ID | Term |
|---|---|
| D025202 | Molecular Diagnostic Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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Peripheral blood samples collected from each study participant.
Determine whether the new biomarkers cancer serve as prognostic biomarkers to predict tumor recurrence and metastasis. |
| 2 years |
| Fudan University Shanghai Cancer Center. | Recruiting | Shanghai | Shanghai Municipality | 200032 | China |
|
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D008919 | Investigative Techniques |
| D005821 | Genetic Techniques |