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Precision medicine approaches emphasize the importance of reliable prognostic tools for guiding individualized therapy decisions. In this study, we evaluated the clinical feasibility of the Single Patient Classifier (SPC) test, a new clinical-grade prognostic assay, in stage II-III gastric cancer patients.
A prospective multicenter study was conducted, involving 237 patients who underwent gastrectomy between September 2019 and August 2020 across nine hospitals. The SPC test was employed to stratify patients into risk groups, and its feasibility and performance were evaluated. The primary endpoint was the proportion of the cases in which the test results were timely delivered before selecting postoperative treatment. Furthermore, 3-year disease-free survivals of risk groups were analyzed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Feasibility cohort | patients who underwent gastrectomy between September 2019 and August 2020 across nine hospitals. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nProfiler I Stomach Cancer Assay Kit | Device | nProfiler I Stomach Cancer Assay Kit (Novomics Co., Korea) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Timely delivered proportion | the proportion of the cases in which the test results were timely delivered before selecting postoperative treatment | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| 3-year disease free survival of the enrolled patients. | Statistical significance (P value of <0.05) | 3-years after the enrollment completion |
| 5-year overall survival of the enrolled patients. |
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Inclusion Criteria:
Exclusion Criteria:
-Those with insufficient quantity or quality of ribonucleic acid (RNA) for analysis were excluded from the study.
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histologically confirmed diagnosis of stage II or III AGC
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| Name | Affiliation | Role |
|---|---|---|
| Young-Woo Kim, MD., Ph.D | National Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novomics. Co., Ltd. | Seoul | 07217 | South Korea |
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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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FFPE samples
Statistical significance (P value of <0.05)
| 5-years after the enrollment completion |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |