ChiCTR1800018467
尚未开始
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2018-09-20
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肝癌
HCC Screening Using DNA Methylation Changes in ctDNA
Clinical Trials on detection of hepatocellular carcinoma (HCC) with non-invasive method based on DNA methylation of circulated tumor DNA, PBMC and T cells
H9K1N2
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
诊断性病例对照试验
诊断试验新技术
N/A
未说明
北京爱普迪医疗诊断技术有限公司
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2019-08-01
2020-01-01
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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.；
请登录查看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.；
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