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

NCT06379334 | Active Not Recruiting

• 1 other identifier: I-22PJ911
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatocellular Carcinoma; Hepatitis B

Outcome Measures

Primary Outcomes (2)

• upregulated proteins

  2024-5

• downregulated proteins

  2024-5

Study Arms (4)

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

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

HC

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

Diagnostic Test: Urine test

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

Interventions

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.

CHB; HC; HCC; Other cancer

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

urine samples

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Hepatitis B

Interventions

Urinalysis

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Urological; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2024
• First Posted: April 23, 2024
• Study Start: December 6, 2020
• Primary Completion: December 6, 2024
• Study Completion (Estimated): December 6, 2026
• Last Updated: April 23, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)