Single Patient Classifier (SPC) Prediction for Stage II and III Advanced Gastric Cancer: a multi-center, retrospective, clinical validatio
- Conditions
- Neoplasms
- Registration Number
- KCT0005536
- Lead Sponsor
- ational Cancer Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 2131
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 with 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 samples between 2005 and 2010
? Patients who have not been included in discovery clinical trial (No. 705) and confirmatory clinical trial (No. 745)
?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.
1)Exclusion 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 (No. 705) and confirmatory clinical trial (No. 745)
? 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
Study & Design
- Study Type
- Observational Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Differences in prognosis between Low risk group and High risk group (AJCC 8th, Advanced gastric cancer stage II and III);Comparability of prognostic stratification with stage II and III advanced gastric cancer based on the 6th and 8th of the AJCC;Prognostic equivalence between surgery only group and adjuvant chemotherapy group in Low risk group
- Secondary Outcome Measures
Name Time Method Multivariate analysis