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

Study Timeline

• Study Start: 2020-12-06
• Status Verified: 2024-04
• Study First Submitted: 2024-04-16
• Study First Submitted QC: 2024-04-18
• Last Update Submitted: 2024-04-18
• Study First Posted: 2024-04-23
• Last Update Posted: 2024-04-23
• Primary Completion: 2024-12-06
• Study Completion: 2026-12-06

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

Name	Time	Method
downregulated proteins	2024-5
upregulated proteins	2024-5

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, China