Evaluation of Survival Prognostic Factors for Patients With Exocrine Pancreatic Cancer Resectable or Potentially Resectable : a Multicentre Prospective Cohort
试验速览
- 阶段
- 不适用
- 入组人数
- 350
- 试验地点
- 9
- 主要终点
- disease-free survival according to the consensus DATECAN (Bonnetain F et al, European Journal of Cancer 2014)
研究概览
简要总结
This study aims to collect clinical, biological and quality of life data from patients with a borderline or resectable pancreatic cancer. It will collect information from the date of diagnosis along the therapeutic care of the patients, and a 3-years follow-up after the end of the treatment. The database will be updated at each patient's visit. Biological samples will include: tumor, and plasma. Epidemiological data will also be collected, whereas Quality of life will be assessed by the EORTC standard. The objectives of this database are to identify new biomarkers (genomic, immunologic, and epidemiologic) and promote high quality standard research protocol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Patients with exocrine resectable pancreatic adenocarcinoma or potentially resectable (that after neoadjuvant treatment are considered appropriate candidates for resection)
- •Histologically or cytologically documented diagnosis of exocrine pancreatic adenocarcinoma
- •Written informed consent obtained prior enrollment in the study
排除标准
- •other types of pancreatic cancer, in particular endocrine tumor or acinar cells
- •ampulloma
- •metastatic disease
- •other malignancy within the last 5 years, except for adequately treated carcinoma in situ of the cervix or squamous carcinoma of the skin, or adequately controlled limited basal cell skin cancer
- •patient with any medical or psychiatric condition or disease which would make the patient inappropriate for entry into this study
- •patient under guardianship, curator or under the protection of justice.
结局指标
主要结局
disease-free survival according to the consensus DATECAN (Bonnetain F et al, European Journal of Cancer 2014)
时间窗: date of first disease apparition [within 3 years after the enrollment of the last patient]
DATECAN = Definition for the Assessment of Time-to-event Endpoints in CANcer trials
次要结局
未报告次要终点