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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Hepatitis B; Hepatocellular Carcinoma
• Intervention / Treatment: Diagnostic test: Urine test

• Study Type: Observational
• Enrollment (Estimated): 180

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Peking Union Medical College Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

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, 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
HCC; Urine samples from patients with chronic hepatitis B related hepatocellular carcinoma were collected and their proteomes were analyzed via liquid chromatography with tandem mass	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.
CHB; Urine samples from patients with chronic hepatitis B were collected and their proteomes were analyzed via liquid chromatography with tandem mass	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.
HC; Urine samples from healthy controls were collected and their proteomes were analyzed via liquid chromatography with tandem mass	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.
Other cancer; Urine samples from other cancer controls were collected and their proteomes were analyzed via liquid chromatography with tandem mass	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
upregulated proteins	2024-5
downregulated proteins	2024-5

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 6, 2020
• Primary Completion (Estimated): December 6, 2024
• Study Completion (Estimated): December 6, 2026

Study Registration Dates

• First Submitted: April 16, 2024
• First Submitted That Met QC Criteria: April 18, 2024
• First Posted (Actual): April 23, 2024

Study Record Updates

• Last Update Posted (Actual): April 23, 2024
• Last Update Submitted That Met QC Criteria: April 18, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Disease Attributes; Digestive System Neoplasms; Liver Diseases; Hepatitis, Viral, Human; Hepadnaviridae Infections; DNA Virus Infections; Liver Neoplasms; Enterovirus Infections; Picornaviridae Infections; Hepatitis, Chronic; Chronic Disease; Carcinoma; Hepatitis B; Hepatitis; Carcinoma, Hepatocellular; Hepatitis A; Hepatitis B, Chronic
• Other Study ID Numbers: I-22PJ911

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No