NCT06379334进行中（未招募）不适用
Identification of Urinary Protein Biomarkers for Hepatocellular Carcinoma in Chronic Hepatitis B Patients
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- downregulated proteins
研究概览
简要总结
Chronic hepatitis B (CHB) can lead to hepatocellular carcinoma (HCC), imposing a significant health and economic burden globally. Early detection of hepatitis B virus-related HCC (HBV-HCC) in CHB with potential biomarkers has become a pressing and difficult challenge. Recent advancements in urinary proteomics offer a promising approach for HBV-HCC biomarker identification, utilizing Liquid chromatography with tandem mass spectrometry for urine proteome analysis. Differential analysis using limma in R software will uncover upregulated proteins in HBV-HCC.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age > 18 years old;
- •Previously healthy individuals without underlying diseases, confirmed to be free of hepatitis B infection through HBV serum markers, with regular physical examinations and blood biochemistry tests;
- •Chronic hepatitis B patients diagnosed through HBV serum markers, alpha-fetoprotein (AFP) concentration, clinical features, or imaging examinations;
- •Hepatitis B-related liver cancer patients with complete clinical data, preoperatively tested positive for HBsAg, diagnosed based on clinical features and imaging examinations preoperatively, and pathologically confirmed with HCC postoperatively;
- •Patients with non-hepatocellular liver cancer, preoperatively diagnosed based on clinical features and imaging examinations, with negative HBsAg, and pathologically or by biopsy confirmed as non-hepatocellular liver cancer without liver metastasis, with complete clinical data and no liver metastasis;
- •Able to independently sign an informed consent form.
排除标准
- •Patients with long-term heavy alcohol consumption;
- •Patients with chronic hepatitis C infection;
- •Patients with autoimmune diseases;
- •Patients who have taken drugs known to have definite hepatotoxicity within the past year;
- •Patients with urinary system infections;
- •Patients with hematuria;
- •Patients with significant proteinuria;
- •Patients with tumors of the urinary system;
- •Patients with acute infectious diseases;
- •Patients with hepatitis B-related liver cancer who also have tumors other than primary hepatocellular carcinoma.
结局指标
主要结局
downregulated proteins
时间窗: 2024-5
upregulated proteins
时间窗: 2024-5
次要结局
未报告次要终点
研究者
研究点 (1)
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