A Pilot Clinical Study to Evaluate the Feasibility of Using the SPC Test
- Conditions
- Gastric Cancer
- Interventions
- Device: nProfiler I Stomach Cancer Assay Kit
- Registration Number
- NCT06521528
- Lead Sponsor
- Novomics. Co., Ltd.
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 237
- being ≥19 years of age
- having a histologically confirmed diagnosis of stage II or III AGC according to the American Joint Committee on Cancer (AJCC) staging system (sixth edition)
- underwent radical gastrectomy without prior neo-adjuvant chemoradiotherapy and did not receive adjuvant chemotherapy
- having no visually or microscopically detectable residual tumors.
-Those with insufficient quantity or quality of ribonucleic acid (RNA) for analysis were excluded from the study.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Feasibility cohort nProfiler I Stomach Cancer Assay Kit patients who underwent gastrectomy between September 2019 and August 2020 across nine hospitals.
- Primary Outcome Measures
Name Time Method Timely delivered proportion 14 days the proportion of the cases in which the test results were timely delivered before selecting postoperative treatment
- Secondary Outcome Measures
Name Time Method 3-year disease free survival of the enrolled patients. 3-years after the enrollment completion Statistical significance (P value of \<0.05)
5-year overall survival of the enrolled patients. 5-years after the enrollment completion Statistical significance (P value of \<0.05)
Trial Locations
- Locations (1)
Novomics. Co., Ltd.
🇰🇷Seoul, Korea, Republic of