Prospective Single-center Study About the Use of Ctdna in the Management of Patients With Tumors of the Gastrointestinal Tract
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- mOS
研究概览
简要总结
This study will evaluate the use of ctDNA in the clinical management of patients with tumors of the gastrointestinal tract.
详细描述
This is a a prospective observational single-center study; it is a spontaneous study, not sponsored by pharmaceutical companies, and does not involve the use of experimental drugs. The study involves a collection of data, carried out while protecting the anonymity and personal information of individual patients suffering from neoplasms of the gastrointestinal tract, the execution of peripheral blood samples and the collection of faecal material at pre-determined times -points. Circulating biomarkers (as ctDNA) will be evaluated in these samples, in order to optimize both the diagnostic and therapeutic processes of patients with tumors of the gastrointestinal tract.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >18 years
- •PS ECOG <2;
- •Histological diagnosis of gastrointestinal cancer: esophageal, gastric, intestinal, pancreatic, biliary tract neoplasms;
- •Radiological evidence of resectable/locally advanced/metastatic disease on the date of signing the written informed consent;
- •Adequate organ and function;
- •Availability of tumor histological material.
排除标准
- •No histological diagnosis of neoplasia of the gastrointestinal tract.
- •No written informed consent.
结局指标
主要结局
mOS
时间窗: 3 years
The primary endpoint of the study is to evaluate the probability of overall survival (mOS) in relation to the expression of specific molecular markers present in the plasma/faeces of patients.
次要结局
未报告次要终点