NCT06355700招募中不适用
Hepatocellular Carcinoma Organoids to Explore Tumor Microenvironment and Test Treatment Efficacy - Hepatocellular Carcinoma Liver Organoids (HELIO)
Fondazione Policlinico Universitario Agostino Gemelli IRCCS2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2023年6月15日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Success rate of hepatocellular carcinoma organoids integrated with host gut microbiota and peripheral blood mononuclear cells
研究概览
简要总结
The goal of this interventional study is to create hepatocellular carcinoma organoids from liver bioptic samples of individuals with hepatocellular carcinoma. The main questions it aims to answer are:
- the feasibility of hepatocellular carcinoma organoids integrated with host gut microbiota and peripheral blood mononuclear cells
- the molecular pattern of the organoid tumor microenvironment
- the in vitro therapeutic response of hepatocellular carcinoma organoids
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
- •Ability to express informed consent
- •Patients ≥ 18 years of age
- •Radiological diagnosis of hepatocellular carcinoma (HCC)
排除标准
- •Patients <18 years of age
- •Contraindications for liver biopsy: ascites, platelet count <50.000, International Normalized Ratio (INR) >1.7
- •Active viral infection
- •Refusal to give informed consent for the study
结局指标
主要结局
Success rate of hepatocellular carcinoma organoids integrated with host gut microbiota and peripheral blood mononuclear cells
时间窗: within 12 months
Number of successfully created organoids from all hepatocellular carcinoma samples
次要结局
- Evaluation of the concordance of somatic genetic mutations between the organoid and the original tumor(within 12 months)
- Correlation between gut microbiota community profiling and growth rate of hepatocellular carcinoma organoids(within 12 months)
- Treatment response evaluation in vitro(Day 5)
- Analysis of hepatocellular carcinoma organoid transcriptome distribution within a reference set from The Cancer Genome Atlas(within 12 months)
研究者
研究点 (2)
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