Prospective assessment of nProfiler® 1 predictive test on prognosis and chemotherapy response for resectable gastric cancer

Not Applicable

Recruiting

• Conditions: Neoplasms

• Registration Number: KCT0005445
• Lead Sponsor: ovomics

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 4 April 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 688

Inclusion Criteria

1) Sample providers criteria
? Male and female adult patients aged 19 years or over
? Patients with histologically confirmed gastric adenocarcinoma
? Patients with histologically confirmed stage ? or ?
? 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)

2) Sample criteria
? The 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 Criteria

1) Sample providers criteria
? Male and female patients aged less than 19 years
? Patients with histologically not confirmed gastric adenocarcinoma
? Patients with histologically confirmed stage ? or ?
? 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)

2) 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

Study & Design

• Study Type: Observational Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prognostic group's 5-yr Overall Survival(OS) rate

Secondary Outcome Measures

Name	Time	Method
Prognostic group's 3-yr Disease Free Survival(DFS) rate;Adjuvant chemotherapy benefit of Low risk (5-yr OS rate, 3 yr DFS rate)