KCT0005536已完成未知
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.
ational Cancer Center0 个研究点目标入组 2,131 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 2,131
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational Study
入排标准
- 年龄范围
- 19(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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
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