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NCT06379334Active, not recruiting

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

Source: ClinicalTrials.gov · Last updated 23 Apr 2024

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Observational
Enrollment
180 (estimated)
First submitted
16 Apr 2024
Start date
Dec 2020
Primary completion date
Dec 2024
Lead sponsor
Peking Union Medical College Hospital
NCT number
NCT06379334

What you commit to

  • Study type: Observational
  • Planned participants: 180
  • From Dec 2020 to the primary completion date, Dec 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patients who have taken drugs known to have definite hepatotoxicity within the past year;

Other illness

  • Patients with chronic hepatitis C infection;
  • Patients with autoimmune diseases;
  • Patients with urinary system infections;
  • Patients with acute infectious diseases;
  • Patients with hepatitis B-related liver cancer who also have tumors other than primary hepatocellular carcinoma.

Other

  • Patients with long-term heavy alcohol consumption;
  • Patients with hematuria;
  • Patients with significant proteinuria;
  • Patients with tumors of the urinary system;

Who the study is looking for

  • 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.

Age in the registry: 18 years to 100 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Peking Union Medical College Hospital
Coordinator of this site? Confirm its status
BeijingChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.