Discovering Urinary Protein Biomarkers for Hepatocellular Carcinoma in Chronic Hepatitis B Population
Active, not recruiting
- Conditions
- Hepatocellular CarcinomaHepatitis B
- Registration Number
- NCT06379334
- Lead Sponsor
- Peking Union Medical College Hospital
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 180
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method downregulated proteins 2024-5 upregulated proteins 2024-5
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Peking Union Medical College Hospital
🇨🇳Beijing, China
Peking Union Medical College Hospital🇨🇳Beijing, China