MedPath

Discovering Urinary Protein Biomarkers for Hepatocellular Carcinoma in Chronic Hepatitis B Population

Active, not recruiting
Conditions
Hepatocellular Carcinoma
Hepatitis 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
  1. Age > 18 years old;
  2. 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;
  3. Chronic hepatitis B patients diagnosed through HBV serum markers, alpha-fetoprotein (AFP) concentration, clinical features, or imaging examinations;
  4. 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;
  5. 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;
  6. Able to independently sign an informed consent form.
Exclusion Criteria
  1. Patients with long-term heavy alcohol consumption;
  2. Patients with chronic hepatitis C infection;
  3. Patients with autoimmune diseases;
  4. Patients who have taken drugs known to have definite hepatotoxicity within the past year;
  5. Patients with urinary system infections;
  6. Patients with hematuria;
  7. Patients with significant proteinuria;
  8. Patients with tumors of the urinary system;
  9. Patients with acute infectious diseases;
  10. 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
NameTimeMethod
downregulated proteins2024-5
upregulated proteins2024-5
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Peking Union Medical College Hospital

🇨🇳

Beijing, China

Peking Union Medical College Hospital
🇨🇳Beijing, China

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