Clinical Trials on Detection of Hepatocellular Carcinoma With Non-invasive Method Based on DNA Methylation of Circulated Tumor DNA, PBMC and T Cells
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 403
- 试验地点
- 1
- 主要终点
- Calculation of M Scores and HCC Probability Scores
研究概览
简要总结
Hepatocellular Carcinoma (HCC) is the fifth most common cancer world-wide. It is particularly prevalent in Asia, and its occurrence is highest in areas where hepatitis B is prevalent, indicating a possible causal relationship. Follow up of high-risk populations such as chronic hepatitis patients and early diagnosis of transitions from chronic hepatitis to HCC would improve cure rates. In most cases HCC is detected late resulting in increased mortality and morbidity.
The purpose of this study is to develop and test non-invasive biomarkers based on methylation changes in PBMC and circulated tumor DNA in hepatocellular carcinomas patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
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
- •Confirmed diagnosis of HCC by EASL-EORTC guidelines
- •Confirmed hepatitis B diagnosis for HepB patients using AASLD practice guidelines.
- •Exclusion Criteria for HCC:
- •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
- •Other cancers.
- •Exclusion Criteria for HepB:
- •Diagnosis of HCC or any other cancer.
- •Exclusion Criteria for Healthy Controls:
- •Any known inflammatory or infectious disease including HepB and HepC
- •Chronic diseases,
- •Medications or drug use
排除标准
- 未提供
结局指标
主要结局
Calculation of M Scores and HCC Probability Scores
时间窗: 6 months to 1 year
We normalized median methylation values (range 0-100) for 'HCC-detect' (Hepatocellular Carcinoma Detection) and 'HCC-spec' (Hepatocellular Carcinoma Specificity). 'HCC-detect' is derived from CHFR, VASH2, CCNJ, and GRID2IP regions, aiming to broadly identify HCC. Theoretical range is -6.6438 to 8.6438, with observed -3.541 to 7.65; higher scores indicate increased HCC likelihood. 'HCC-spec', focusing on the F12 region, differentiates HCC from 31 other cancers and normal cells, with theoretical range -3.3219 to 6.64385 (observed -3.3219 to 6.6297). Higher scores signify greater HCC specificity. Both scores, modeled via logistic regression in Prism, predict HCC probability, linking higher scores with higher HCC likelihood or specificity
次要结局
未报告次要终点