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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Hepatocellular Carcinoma Adenocarcinoma Blood-Borne Infections Carcinoma Carcinoma, Hepatocellular Communicable Diseases DNA Virus Infections Digestive System Diseases Digestive System Neoplasms Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis, Viral, Human Infections Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Virus Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Peking Union Medical College Hospital

Beijing, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age > 18 years old;
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;
Chronic hepatitis B patients diagnosed through HBV serum markers, alpha-fetoprotein (AFP) concentration, clinical features, or imaging examinations;
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;
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;
Able to independently sign an informed consent form.

Exclusion criteria

Patients with long-term heavy alcohol consumption;
Patients with chronic hepatitis C infection;
Patients with autoimmune diseases;
Patients who have taken drugs known to have definite hepatotoxicity within the past year;
Patients with urinary system infections;
Patients with hematuria;
Patients with significant proteinuria;
Patients with tumors of the urinary system;
Patients with acute infectious diseases;
Patients with hepatitis B-related liver cancer who also have tumors other than primary hepatocellular carcinoma.

Treatment and study plan

Urine test

Diagnostic 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.

Primary outcomes

upregulated proteins

Time frame: 2024-5
downregulated proteins

Time frame: 2024-5

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Registry information

Official study title

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

Important dates

Study start: 2020
Primary completion: 2024
Study completion: 2026
First posted: Apr 23, 2024
Registry last updated: Apr 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Active, Not Recruiting