Status:
ACTIVE_NOT_RECRUITING
Prospective Assessment of nProfiler® 1 on Prognosis and Chemotherapy Response for Gastric Cancer
Lead Sponsor:
Novomics. Co., Ltd.
Conditions:
Gastric Cancer
Eligibility:
All Genders
19+ years
Brief Summary
Prospective assessment of nProfiler® 1 predictive test on prognosis and chemotherapy response for resectable gastric cancer
Detailed Description
1. Background: According to Global Cancer Statistics of International Agency for Research on Cancer under World Health Organization, stomach cancer is the fifth most common cancer as there were over 1...
Eligibility Criteria
Inclusion
- Sample providers criteria
- Male and female adult patients aged 19 years or over
- Patients with histologically confirmed gastric adenocarcinoma
- Patients with histologically confirmed stage Ⅱ or Ⅲ
- Patients who have undergone radical gastrectomy
- Patients who have not received neoadjuvant chemotherapy and radiotherapy
- Patients who have undergone a radical gastrectomy and who show no evidence of residual tumors as observed with the unaided eye or through a microscope
- Patients who have signed a written consent of the study and signed a human derived research agreement (Form 34)
- Sample criteria
- The formalin-fixed paraffin-embedded (FFPE) tumor specimens in storage have a tumor amount of at least 20% and therefore 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
- Sample providers criteria
- Male and female patients aged less than 19 years
- Patients with histologically not confirmed gastric adenocarcinoma
- Patients with histologically confirmed stage Ⅰ or Ⅳ
- Patients who have not undergone radical gastrectomy
- Patients who have received neoadjuvant chemotherapy or radiotherapy
- Patients with distant or peritoneal metastasis at the time of surgery or residual tumors after surgery
- Patients who have not signed the study's written consent and human derived research agreement (Form 34)
- Sample criteria
- The FFPE tumor specimens in storage have a tumor amount of less than 20% and therefore cannot be tested
- The quantity and quality of RNA are not sufficient for analysis
Key Trial Info
Start Date :
July 29 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2029
Estimated Enrollment :
581 Patients enrolled
Trial Details
Trial ID
NCT04487717
Start Date
July 29 2020
End Date
December 31 2029
Last Update
December 17 2024
Active Locations (1)
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1
Novomics
Seoul, South Korea, 07217