Biomoleculars Markers of Sensitivity to Pre- and Post-operative Chemotherapy of Gastric and Cardia Adenocarcinomas: a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Assessment of expression level of FGFR2
研究概览
简要总结
Some subtypes of gastric and cardia tumors such as adenocarcinoma or gastric linitis with disseminated cells respond poorly to the pre-operative chemotherapy, and some of them do not respond to chemotherapy usually performed. Doing chemotherapy in these patients could delay their surgical management. The completion of chemotherapy for these patients would be a bad prognosis factor according to recent data from the literature. Therefore, the aim of this research is to find prognostic markers of sensitivity to chemotherapy usually performed. The investigators are going to use biopsies realized at diagnosis and select patients "good and bad" responders.
Primary purpose:
To study cardia and gastric tumors, molecular markers sensitivity to pre- and post- perative chemotherapy protocols (EOX protocol ... FOLFOX) or chemoradiation
Secondary purposes:
- To assess the impact of patients' lifestyle (via a questionnaire) on the response to chemotherapy
- To study markers of cancer stem cells
- To correlate clinical and molecular markers with patient survival and quality of life questionnaires
- To characterize the expression levels (Met, Her2, FGFR2) and mutations (p53 ras) in frequently deregulated genes in gastric cancers.
- To characterize the level of expression of predictive candidate markers (ΔNp73, TAp73, HDAC4, mir140, EZH2, CXCL12, CXCR4, CXCR7) found in the literature.
- To correlate the abnormalities found in the with tumor stages (before and after chemotherapy) and with 5 years overall survival and progression-free patients
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gastric adenocarcinoma (any location) or cardia adenocarcinoma
- •Age> 18 years
- •WHO Index≤ 3
- •Subject having signed an informed consent
排除标准
- •Other cancers undergoing chemotherapy treatment
- •Pregnant or breastfeeding
- •Inability to understand information (understanding with difficulties ...)
结局指标
主要结局
Assessment of expression level of FGFR2
时间窗: at 15 days
To search in gastric and cardia tumors molecular markers of sensitivity to pre- and post-operative chemotherapy protocols (EOX protocol ... FOLFOX) or chemoradiation
Assessment of expression level of Met
时间窗: at 15 days
To search in gastric and cardia tumors molecular markers of sensitivity to pre- and post-operative chemotherapy protocols (EOX protocol ... FOLFOX) or chemoradiation
Assessment of expression level of Her2
时间窗: at 15 days
To search in gastric and cardia tumors molecular markers of sensitivity to pre- and post-operative chemotherapy protocols (EOX protocol ... FOLFOX) or chemoradiation
次要结局
未报告次要终点