Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-25 @ 4:58 AM
NCT ID:
NCT04600518
Eligibility Criteria:
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 and having 3 or more lymph nodes metastasis or who with gastric cancer infiltration of muscularis propria and lymph node metastasis (stage II and III advanced gastric cancer patients, 8th of the AJCC)
* Patients who have not received neoadjuvant chemotherapy and radiotherapy
* Patients with pathological record and clinical information after surgery from archived FFPE(formalin-fixed paraffin-embedded) samples between 2005 and 2010
* Patients who have not been included in discovery clinical trial and confirmatory clinical trial
* 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
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
* Postoperative patients with gastric cancer invading the mucosa and submucosal layer and having less than 3 lymph nodes metastasis or who with gastric cancer infiltration of muscularis propria without lymph node metastasis (stage II and III advanced gastric cancer patients, 8th of the AJCC)
* Patients who have received neoadjuvant chemotherapy or radiotherapy
* Patients without pathological record and clinical information after surgery from archived FFPE samples between 2005 and 2010
* Patients who have been included in discovery clinical trial and confirmatory clinical trial
* Patients with residual tumors after surgery
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Study:
NCT04600518
Study Brief:
Protocol Section:
NCT04600518