Peptide-based Immunization for Colon- and Pancreas-carcinoma (PICOP-GLOBAL): An International, Multicenter Protocol
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Identification of tumor specific mutations on the genomic level
研究概览
简要总结
An international, multicenter study to identify tumor molecular particularities and neoepitopes among participants with colorectal and pancreatic tumors undergoing surgery.
详细描述
Colorectal and pancreatic cancers are among the most common causes of cancer-related death over the world. Standard of care treatment for colon and pancreas cancer is stage dependent and includes surgical, chemotherapeutic, and radiation therapy. However, the current statistics underlines an urgent need for improved treatment. Patient-individualized treatments and enhancement of the immune response via vaccination are among new therapeutic options.
The enhancement of the immune response via vaccination is among new therapeutic options. Here, either cell-specific antigens, over-expressed tumor specific antigens or mutated tumor-specific antigens (neoepitopes) can be employed. Especially the latter possess the biggest potential for high specificity but presuppose an extensive characterization of the respective tumor. In order to identify a neoepitope-based vaccination approach for patient-individualized treatment options the molecular particularities of tumors have to be analysed.
The aim of this study is to identify tumor molecular particularities and neoepitopes among patients with colorectal and pancreatic tumors undergoing surgery.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Informed consent is obtained from the participant
- •Patients with pancreas or colorectal carcinoma undergoing surgery
- •The participant is older than 18 years old
排除标准
- •Inability to provide informed consent
- •The patient is not suffering from pancreas or colo-rectal carcinoma
- •Patient has a condition contradicting surgery
- •The participant is younger than 18 years old
- •Previously enrolled in the study
结局指标
主要结局
Identification of tumor specific mutations on the genomic level
时间窗: 24 months
Identification of tumor specific mutations on the genomic level using whole exome sequencing and/or whole genome sequencing
次要结局
- Identification of tumor specific mutations on transcriptional and/or translational level(24 months)
- Identification of neo-antigens epitopes at protein level(24 months)