Gastrointestinal Microflora and Serum Metabolomics in Patients With Pancreatic Cancer and Chronic Pancreatitis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Gastrointestinal microbiota
研究概览
简要总结
The investigators plan to collect throat swabs, saliva, feces and serum samples from pancreatic cancer patients, chronic pancreatitis patients and healthy people and clarify the characteristics of oral flora and serum metabolome of pancreatic cancer patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •1.Pathologic diagnosis of pancreatic ductal adenocarcinoma；Diagnosis of CP defined as having obvious morphological features of CP (i.e., the presence of pancreatic calcifications on CT scan and/or magnetic resonance cholangiopancreatography)；Other benign disease populations without pancreatic lesions.
排除标准
- •Pregnant women.
- •Patients with coagulation disorders who are unable to undergo blood tests.
- •Have a history of using antibiotics or probiotics within the past 3 months.
结局指标
主要结局
Gastrointestinal microbiota
时间窗: Baseline
Perform 16S RNA sequence and shotgun metagenomic analysis of fecal, throat swabs and salivary samples collected from pancreatic cancer patients, chronic pancreatitis patients and healthy people.
Overall Survival
时间窗: up to 2 years
The length of time (in days) from study enrollment that participants remain alive.
Predictive model
时间窗: up to 2 years
Combined with preoperative imaging and pathological information, a predictive model of pancreatic cancer would be established based on the metabolic and microbiota difference. Verify the stability and accuracy of our model in larger cohorts and promote clinical translation.
serum metabolites
时间窗: Baseline
Perform Untargeted liquid chromatography-tandem mass spectrometry (LC-MS/MS) to analyse serum samples collected from pancreatic cancer patients, chronic pancreatitis patients and healthy people.
次要结局
未报告次要终点
研究者
Xiangyu Kong
Principle Investigator
Changhai Hospital