【ChiCTR1800018467】HCC Screening Using DNA Methylation Changes in ctDNA

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基本信息

登记号

ChiCTR1800018467

试验状态

尚未开始

药物名称

药物类型

规范名称

首次公示信息日的期

2018-09-20

临床申请受理号

靶点

适应症

肝癌

试验通俗题目

HCC Screening Using DNA Methylation Changes in ctDNA

试验专业题目

Clinical Trials on detection of hepatocellular carcinoma (HCC) with non-invasive method based on DNA methylation of circulated tumor DNA, PBMC and T cells

申办单位信息

申请人联系人

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申请人名称

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联系人邮箱

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联系人邮编

H9K1N2

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临床试验信息

试验目的

Primary objective: To develop and test non-invasive biomarkers based on methylation changes in PBMC, T-cells and circulated tumor DNA in hepatocellular carcinomas patients. Secondary objectives: 1. To assess and analyze DNA methylation level of targeted CpG sites in PBMC, T-cells and circulated tumor DNA in plasma of HCC patients, chronic hepatitis patients and in healthy aged and sex matched controls. 2. Determine the specificity and sensitivity of the tested biomarkers. 3. Determine the methylation score of the tested biomarkers for early detection of HCC

试验分类

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试验类型

诊断性病例对照试验

试验分期

诊断试验新技术

随机化

N/A

盲法

未说明

试验项目经费来源

北京爱普迪医疗诊断技术有限公司

试验范围

目标入组人数

实际入组人数

第一例入组时间

2019-08-01

试验终止时间

2020-01-01

是否属于一致性

入选标准

For HCC patient inclusion criteria include confirmed diagnosis of HCC by EASL-EORTC guidelines and confirmed hepatitis B diagnosis for HepB patients using AASLD practice guidelines. Healthy controls will be matched to the patient group for age, sex, smoking and alcohol consumption. Whole-blood specimens will be ideally collected before start of standard therapy.；

排除标准

For HCC a strict exclusion criterion is cirrhosis, any other known inflammatory disease (bacterial or viral infection with the exception of hepatitis B or C, diabetes, asthma, autoimmune disease, active thyroid disease) which could alter T cells and monocytes characteristics as well as other cancers. For HepB patient exclusion criteria in addition to the above will be diagnosis of HCC or any other cancer. For healthy controls, exclusion criteria include any known inflammatory or infectious disease including HepB and HepC and any diagnosis of chronic disease, cancer, medications use, or drugs of abuse.；

研究者信息

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试验机构

北京爱普迪医疗诊断技术有限公司

研究负责人电话

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研究负责人邮箱

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研究负责人邮编

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