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

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Active, not recruiting

Conditions: Hepatocellular Carcinoma; Hepatitis B

Treatments: Diagnostic Test: Urine test

Study type: Observational

Funder types: Other

Identifiers

NCT06379334

I-22PJ911

Details and patient eligibility

About

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.

Enrollment: 180 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

180 participants in 4 patient groups

HCC

Description:

Urine samples from patients with chronic hepatitis B related hepatocellular carcinoma were collected and their proteomes were analyzed via liquid chromatography with tandem mass

Treatment:

Diagnostic Test: Urine test

CHB

Description:

Urine samples from patients with chronic hepatitis B were collected and their proteomes were analyzed via liquid chromatography with tandem mass

Treatment:

Diagnostic Test: Urine test

HC

Description:

Urine samples from healthy controls were collected and their proteomes were analyzed via liquid chromatography with tandem mass

Treatment:

Diagnostic Test: Urine test

Other cancer

Description:

Urine samples from other cancer controls were collected and their proteomes were analyzed via liquid chromatography with tandem mass

Treatment:

Diagnostic Test: Urine test