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This study is designed to investigate whether complement C3 depletion is associated with poor short-term outcomes in postoperative patients with gastric cancer.
The complement system plays an important role in the development of digestive malignancies. The complement C3 is the point of convergence for the three complement activation pathways. However, the concrete effect of C3 in the development of gastric cancer is still obscured. This study is designed to explore whether complement C3 can be regarded as a predictive factor of postoperative outcomes for postoperative patients with gastric cancer.
This study is designed as a prospective cohort study and included consecutively treated patients. The perioperative plasma value of complement components, such as C3, C4, and CH50, are detected to explore the incidence rate of complement depletion. All enrolled patients are divided into two groups mainly according to the levels of preoperative C3 levels (C3 depletion and Non-C3 depletion groups). The primary endpoints are the 1-year overall survival and disease-free survival, while the secondary endpoints are postoperative complications, length of hospital stay, and hospital charges.
This study would be helpful to confirm the role of complement depletion in anticipated outcomes of postoperative patients with gastric cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| C3 Depletion | Patients with persistent low-level of complement C3 within the perioperative period would be assigned into this main observational group. After a careful multidisciplinary treatment (MDT) discussion, a radical operation with gastrectomy plus D2 lymphadenectomy would be performed, followed by an adjuvant chemotherapy if required. Generally, SOX chemo regimen (S-1+Oxaliplatin) would be first considered for the candidates. |
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| Non-C3 depletion | Patients with normal plasma values of complement C3 within the perioperative period would be assigned into this control group. Those patients would undergo the same decision making process to determine the final treatment plan. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| gastrectomy plus D2 lymphadenectomy | Procedure | A classic total or subtotal gastrectomy plus D2 lymph nodes dissection would be performed for all enrolled patients. Patients in both groups would undergo the identical therapeutic approach for gastric cancer, mainly decided by a multidisciplinary treatment group in our center. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | 1-year overall survival (OS) would be regarded as primary endpoint of this study. | one year after surgery |
| Disease-Free Survival | 1-year disease-free survival (DFS) would be also regarded as primary endpoint of this study. | One year after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Early complications | Early postoperative events should include intra-abdominal infection, postoperative hemorrhage, anastomotic leak, surgical site infection, ileus, and so on. Number of such events would be recorded to calculate incidence. | within 30 days after a radical operation |
| Length of hospital stay |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who have a confirmed pathological diagnosis of gastric adenocarcinoma would be selected for further observation. Those patients who subsequently underwent a radical tumor resection can be included for final analysis.
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| Name | Affiliation | Role |
|---|---|---|
| Yulong He, MD | First Hospital, Sun Yat-sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Sun Yat-sen University | Guangzhou | Guangdong | 510000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31928530 | Derived | Yuan K, Ye J, Liu Z, Ren Y, He W, Xu J, He Y, Yuan Y. Complement C3 overexpression activates JAK2/STAT3 pathway and correlates with gastric cancer progression. J Exp Clin Cancer Res. 2020 Jan 13;39(1):9. doi: 10.1186/s13046-019-1514-3. |
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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 |
|---|---|
| D005743 | Gastrectomy |
| ID | Term |
|---|---|
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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| S-1+Oxaliplatin | Drug | A postoperative systemic chemotherapy would be performed for some subjects who have advanced gastric cancer. The concrete chemo regimen for adjuvant chemotherapy is also determined by a MDT group. Generally, SOX chemo regimen is the first-line treatment in our center, as following described:
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Time frame would cover the period from admission to discharge from hospital. An average of 4 weeks is expected. |
| an expected average of 4 weeks after admission |
| Expenditure of hospitalization | The total costs during the hospitalization would be summarized. | an expected average of 4 weeks after admission |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |