Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-25 @ 4:58 AM
NCT ID:
NCT04600518
Brief Summary:
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
Detailed Description:
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:
NCT04600518
Study Brief:
Protocol Section:
NCT04600518