Single Patient Classifier (SPC) Prediction for Stage II and III Advanced Gastric Cancer

Last updated: July 19, 2024
Sponsor: Novomics. Co., Ltd.
Overall Status: Completed

Phase

N/A

Condition

Gastric Cancer

Stomach Cancer

Digestive System Neoplasms

Treatment

nProfiler I Stomach Cancer Assay Kit

Clinical Study ID

NCT04600518
NM-CTP-04
  • Ages > 19
  • All Genders

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Sample providers criteria
  • Male and female adult patients aged 19 years or over

  • Postoperative patients with gastric cancer invading the submucosal layer andhaving 3 or more lymph nodes metastasis or who with gastric cancer infiltrationof muscularis propria and lymph node metastasis (stage II and III advancedgastric cancer patients, 8th of the AJCC)

  • Patients who have not received neoadjuvant chemotherapy and radiotherapy

  • Patients with pathological record and clinical information after surgery fromarchived FFPE(formalin-fixed paraffin-embedded) samples between 2005 and 2010

  • Patients who have not been included in discovery clinical trial andconfirmatory clinical trial

  • Patients who have undergone a radical gastrectomy and who show no evidence ofresidual tumors as observed with the unaided eye or through a microscope

  1. Sample criteria
  • The FFPE tumor specimens in storage have a tumor amount of at least 20% andtherefore can be tested.

  • The quantity (not less than 400ng) and quality (A260/280 of not less than 1.8)of RNA are sufficient for analysis.

Exclusion

Exclusion Criteria:

  1. Sample providers criteria
  • Male and female patients aged less than 19 years

  • Postoperative patients with gastric cancer invading the mucosa and submucosallayer and having less than 3 lymph nodes metastasis or who with gastric cancerinfiltration of muscularis propria without lymph node metastasis (stage II andIII advanced gastric cancer patients, 8th of the AJCC)

  • Patients who have received neoadjuvant chemotherapy or radiotherapy

  • Patients without pathological record and clinical information after surgeryfrom archived FFPE samples between 2005 and 2010

  • Patients who have been included in discovery clinical trial and confirmatoryclinical trial

  • Patients with residual tumors after surgery

  1. Sample criteria
  • The FFPE tumor specimens in storage have a tumor amount of less than 20% andtherefore cannot be tested

  • The quantity and quality of RNA are not sufficient for analysis

Study Design

Total Participants: 2047
Treatment Group(s): 1
Primary Treatment: nProfiler I Stomach Cancer Assay Kit
Phase:
Study Start date:
October 07, 2020
Estimated Completion Date:
June 22, 2023

Study 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.

Connect with a study center

  • Novomics. Co., Ltd.

    Seoul, 07217
    Korea, Republic of

    Site Not Available

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