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

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06379334
• Other study ID #: I-22PJ911
• Status: Active, not recruiting
• Start date: December 6, 2020
• Est. completion date: December 6, 2026

Study information

• Verified date: April 2024
• Source: Peking Union Medical College Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 180
• Est. completion date: December 6, 2026
• Est. primary completion date: December 6, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic
• Hepatocellular Carcinoma

Intervention

Diagnostic Test:
• Urine 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.

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	upregulated proteins		2024-5
Primary	downregulated proteins		2024-5