Confirmation of Association Between Cell-free Nucleic Acid in Blood and Urine Samples and Microbiome in Stool With Pancreatobiliary Cancer and Study Related to Exploration of Biomarkers in Diagnosis and Treatment of Pancreatobiliary Cancers
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- correlation of genetic mutation burden and prognosis
研究概览
简要总结
Based on the cell free nucleic acid analysis information of blood samples, the results of microbiome and metabolite analysis of stool and urine samples of pancreatic cancer and bile duct cancer patients, the clinical correlations of them with primary cancer are evaluated. And based on these information, biomarkers for diagnosis, treatment, and prognosis of pancreatic and bile duct cancer are explored.
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
- 是
入选标准
- •Patients diagnosed with pancreatic cancer through histological or radiologic examination and before treatment begins
- •Patients diagnosed with biliary tract cancer (cholangiocarcinoma, gallbladder cancer) through histological or radiologic examination and before treatment begins
- •Patients aged 18 or older who voluntarily agrees to participate in the study and is willing to understand and comply with the subsequent treatment procedures and sample collection schedule
排除标准
- •Where the subject himself/herself refuses to fill out the consent form or is unable to fill out the consent form
- •In the case where the sample storage conditions suggested by the reagent manufacturer are not satisfied
- •Only samples that can cause errors when determining results are acquired:
- •Heat treated specimen
- •Incompletely coagulated serum and bacterial samples ③ Samples with particulate matter elements (e.g., fibroblasts, red blood cells) remaining in the sample
- •④ Specimens previously frozen and stored with blood clots that have confirmed an increase in non-specific reactivity in which samples appear to have denatured during storage
- •⑤ Sample from deceased patient
- •⑥ A patient specimen with a malignancy of ohter site
- •⑦ Sample from vulnerable persons such as pregnant women, minors, etc
结局指标
主要结局
correlation of genetic mutation burden and prognosis
时间窗: the day of study enrollment and follow-up till end of the study
correlation of genetic mutation burden and prognosis
correlation of genetic mutation
时间窗: the day of study enrollment or the day of tissue and blood acquisition
concordance of genetic mutation between tissue and blood of treatment-naive status
次要结局
- correlation of microbiome in stool and prognosis(the day of study enrollment and follow-up till end of the study)
- correlation of metabolic change in urine metabolite and prognosis(the day of study enrollment and follow-up till end of the study)
研究者
Sang Hyub Lee
Professor
Seoul National University Hospital