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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 post-operative monitoring of gastric cancer.
This study aims to develop and validate a new non-invasive detection method for postoperative monitoring of gastric cancer in the blood. Blood will also be collected at various time points post-operatively. We will determine whether these new biomarkers can be used as prognostic biomarkers to predict tumor recurrence and metastasis. We 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DNA test | Diagnostic Test | a new non-invasive detection method for postoperative monitoring of gastric cancer in the blood |
|
| Measure | Description | Time Frame |
|---|---|---|
| The performance of the new biomarkers in the post-operative monitoring of gastric cancer | Number of Participants With Tumor Recurrence Detected by the New System vs. Imaging and Serum Markers (CA19-9, CEA, CA72-4). | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Metastasis Detection Time: New vs. Conventional Methods | Time to Detection of Metastasis (Days) by the New System Compared to Conventional Methods. | 2 years |
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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 258 subjects are targeted to enroll.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dazhi Xu, MD., PhD, | Contact | +86 13862036541 | jiangnan@sz-hoho.com |
| Name | Affiliation | Role |
|---|---|---|
| Dazhi Xu, MD., PhD, | Fudan University | Principal Investigator |
| 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.
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D008919 | Investigative Techniques |
| D005821 | Genetic Techniques |