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

Identification of Urinary Protein Biomarkers for Hepatocellular Carcinoma in Chronic Hepatitis B Patients

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06379334
Enrollment
180
Registered
2024-04-23
Start date
2020-12-06
Completion date
2026-12-06
Last updated
2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatocellular Carcinoma, Hepatitis B

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.

Interventions

DIAGNOSTIC_TESTUrine test

Urine samples were collected and their proteomes were analyzed via liquid chromatography with tandem mass spectrometry using data-dependent acquisition or parallel reaction monitoring.

Sponsors

Peking Union Medical College Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frame
upregulated proteins2024-5
downregulated proteins2024-5

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026