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NCT07036874Recruiting

Non-invasive Assessment for Outcome Prediction in Patients With Hepatocellular Carcinoma

Validation of Baveno VII Criteria and Spleen Stiffness Measurement on Outcome Prediction in Patients With Hepatocellular Carcinoma

Source: ClinicalTrials.gov · Last updated 20 Oct 2026

Brief summary (registry, in English)

This is a single-centre, prospective cohort study. Consecutive patients with compensated liver disease and hepatocellular carcinoma (HCC) for curative-intent treatment will be invited to this study. The study follow-up duration will be five years. The primary outcome is the composite of incident high-risk varices, hepatic decompensation and liver-related mortality. The participants will undergo transient elastography at baseline and then half-yearly post-HCC curative treatment; and oesophagogastroduodenoscopy (OGD) at baseline and then at year 1, 3 and 5 post-HCC curative treatment. Clinical assessments and laboratory tests will also be done at baseline and every 6 months until year 5 to identify any clinical events.

Status (registry)
Recruiting
Study type
Observational
Enrollment
159 (estimated)
First submitted
17 Jun 2025
Start date
4 Nov 2024
Primary completion date
31 Dec 2030
Lead sponsor
Chinese University of Hong Kong
NCT number
NCT07036874

What you commit to

  • Study type: Observational
  • Planned participants: 159
  • From 4 Nov 2024 to the primary completion date, 31 Dec 2030
  • 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

  • Current or history of decompensated liver cirrhosis (i.e. Child's C cirrhosis, prior decompensating events such as ascites, variceal bleeding, hepatic encephalopathy and hepatorenal syndrome)
    • o Child's B cirrhosis without decompensating events is not excluded
  • Past history of HCC (ie. The current HCC is a recurrence of priorly treated HCC or a second de novo HCC after previous first HCC)

Other illness

  • History of liver transplantation or plan for liver transplantation as the modality of curative-intent HCC treatment
  • Asplenism or history of splenectomy
  • Contraindication to OGD (eg. Intestinal perforation of obstruction)
  • Serious medical illness with limited life expectancy of less than 6 months

Other

  • Non-primary liver tumour (such as secondary liver tumour due to metastasis from another distant primary tumour)
  • Pregnancy
  • Unable to obtain or refusal of informed consent from patient

Who the study is looking for

  • Aged 18 or above
  • Known chronic liver disease(s)
  • HCC for curative-intent treatment (defined by HCC diagnosed with typical radiological features or histology, and planned for surgical resection or local ablative therapy as a curative-intent treatment)

Age in the registry: 18 years to - · Sex: All · Does not accept 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
Prince of Wales Hospital
Coordinator of this site? Confirm its status
Hong KongHong Kong SAR ChinaRecruiting

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