A retrospective, multi-center, single-blind, pivotal trial to assess clinical equivalence with stage II and III advanced gastric cancer based on the 6th and 8th of the AJCC
The safety and effectiveness of nProfiler® 1 Stomach Cancer Assay have been evaluated with stage II and III advanced gastric cancer patients based on the 6th of the American Joint Committee on Cancer (AJCC) through discovery clinical trial (418 patients) and confirmatory clinical trial (684 patients). The goal of this study, a retrospective, multi-center, single-blind, pivotal trial, is to assess clinical equivalence with stage II and III advanced gastric cancer based on the 6th and 8th of the AJCC and to evaluate prognostic equivalence between surgery only group and adjuvant chemotherapy group in Low risk group. The study will follow these procedures; Sample screening, Sample Preparation and Sample Criteria Evaluation, Sample enrollment, nProfiler® 1 Stomach Cancer Assay (gastric cancer prognosis prediction), Prognostic Result Report, and Evaluation of Clinical Performance.
Study Type
OBSERVATIONAL
Enrollment
2,047
nProfiler I Stomach Cancer Assay Kit (Novomics Co., Korea)
Novomics. Co., Ltd.
Seoul, South Korea
Differences in prognosis
Differences in prognosis between Low risk group and High risk group (AJCC 8th, Advanced gastric cancer stage II and III)
Time frame: 5 years after the date of surgery for patients in Low risk group and High risk group
Comparability of prognostic stratification
Comparability of prognostic stratification with stage II and III advanced gastric cancer based on the 6th and 8th of the AJCC
Time frame: 5 years after the date of surgery for patients in Low risk group and High risk group
Prognostic equivalence
Prognostic equivalence between surgery only group and adjuvant chemotherapy group in Low risk group
Time frame: 5 years after the date of surgery for patients in surgery only group and adjuvant chemotherapy group in Low risk group
Multivariate analysis
Multivariate analysis with age, sex, TNM stage, adjuvant-chemotherapy
Time frame: 5 years after the date of surgery for patients with stage II-III advanced gastric cancer (8th of the AJCC)
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