NCT07764835

Brief Summary

This prospective multicenter observational study evaluates the performance of a structured hepatocellular carcinoma (HCC) surveillance program in patients at increased risk of developing liver cancer. Participants will undergo routine surveillance with semiannual abdominal ultrasound reported using the Ultrasound Liver Imaging Reporting and Data System (US LI-RADS) and serum alpha-fetoprotein (AFP) testing as part of standard clinical care. The study aims to assess HCC detection rates, stage at diagnosis, detection of other hepatic malignancies, and the time intervals between detection, diagnosis, and treatment in a real-world setting. Approximately 300 participants will be enrolled and followed for up to 36 months.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
34mo left

Started Sep 2026

Typical duration for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 10, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 14, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

September 15, 2026

Expected
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2029

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2029

Last Updated

August 14, 2026

Status Verified

August 1, 2026

Enrollment Period

2.8 years

First QC Date

August 10, 2026

Last Update Submit

August 10, 2026

Conditions

Hepatocellular CarcinomaLiver CirrhosisChronic Hepatitis BMetabolic Dysfunction-Associated Steatotic Liver DiseaseAdvanced Liver Fibrosis

Keywords

HCCHepatocellular CarcinomaLiver CancerHCC SurveillanceUS LI-RADSUltrasound LI-RADSAlpha-FetoproteinAFPLiver CirrhosisChronic Hepatitis BMASLDMetabolic Dysfunction-Associated Steatotic Liver DiseaseReal-World StudyObservational StudyEarly DetectionBCLCRede D'OrBrazil

Outcome Measures

Primary Outcomes (1)

  • Annual Incidence Rate of Hepatocellular Carcinoma

    Incidence of newly diagnosed hepatocellular carcinoma among participants enrolled in the structured surveillance program

    Up to 36 months

Secondary Outcomes (1)

  • Early-Stage HCC Detection Rate

    Up to 36 months

Study Arms (1)

At-Risk Patients Under Structured HCC Surveillance

Adult participants at increased risk of hepatocellular carcinoma, including patients with cirrhosis, chronic hepatitis B, advanced fibrosis, or metabolic dysfunction-associated steatotic liver disease, enrolled in a structured surveillance program consisting of semiannual ultrasound using US LI-RADS and alpha-fetoprotein assessment as part of routine clinical care.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients at increased risk for hepatocellular carcinoma, including individuals with liver cirrhosis, chronic hepatitis B, advanced fibrosis, and metabolic dysfunction-associated steatotic liver disease who are receiving routine care within the Rede D'Or healthcare network.

You may qualify if:

  • Written informed consent.
  • Age 18 years or older.
  • Liver cirrhosis of any etiology.
  • Chronic hepatitis B with moderate or high risk of HCC according to PAGE-B criteria.
  • Non-cirrhotic chronic liver disease with increased risk for HCC, including fibrosis stage 3 or higher or metabolic dysfunction-associated steatotic liver disease (MASLD) with one or more risk factors for HCC.
  • Followed at hepatology clinics within the Rede D'Or health network.
  • Eligible for routine HCC surveillance with ultrasound and alpha-fetoprotein according to standard clinical practice.

You may not qualify if:

  • Known hepatocellular carcinoma at enrollment.
  • Previous diagnosis of hepatocellular carcinoma.
  • Metastatic liver disease.
  • Other malignant liver tumors present at enrollment.
  • Clinical condition preventing routine surveillance follow-up.
  • Inability to provide informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Fonseca LG, Chen ATC, de Oliveira IS, Chagas AL, Kruger JAP, Carrilho FJ. Brazilian Landscape of Hepatocellular Carcinoma. JCO Glob Oncol. 2023 Jun;9:e2200416. doi: 10.1200/GO.22.00416.

    PMID: 37348031BACKGROUND

  • European Association for the Study of the Liver. EASL Clinical Practice Guidelines on the management of hepatocellular carcinoma. J Hepatol. 2025 Feb;82(2):315-374. doi: 10.1016/j.jhep.2024.08.028. Epub 2024 Dec 17.

    PMID: 39690085BACKGROUND

  • Singal AG, Llovet JM, Yarchoan M, Mehta N, Heimbach JK, Dawson LA, Jou JH, Kulik LM, Agopian VG, Marrero JA, Mendiratta-Lala M, Brown DB, Rilling WS, Goyal L, Wei AC, Taddei TH. AASLD Practice Guidance on prevention, diagnosis, and treatment of hepatocellular carcinoma. Hepatology. 2023 Dec 1;78(6):1922-1965. doi: 10.1097/HEP.0000000000000466. Epub 2023 May 22. No abstract available.

    PMID: 37199193BACKGROUND

  • Singal AG, Zhang E, Narasimman M, Rich NE, Waljee AK, Hoshida Y, Yang JD, Reig M, Cabibbo G, Nahon P, Parikh ND, Marrero JA. HCC surveillance improves early detection, curative treatment receipt, and survival in patients with cirrhosis: A meta-analysis. J Hepatol. 2022 Jul;77(1):128-139. doi: 10.1016/j.jhep.2022.01.023. Epub 2022 Feb 6.

    PMID: 35139400BACKGROUND

MeSH Terms

Conditions

Carcinoma, HepatocellularLiver CirrhosisHepatitis B, ChronicLiver Neoplasms

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and SymptomsHepatitis BBlood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitis, ChronicHepatitisChronic DiseaseDisease Attributes

Study Officials

  • Leonardo G Fonseca, MD, MSc

    D'Or Institute for Research and Education (IDOR)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Guilherme C Ambrósio, MSc

CONTACT

+55 11 972763211guilherme.ambrosio@idor.org

Escritório O Operações

CONTACT

gestao.ensaiosclinicos@idor.org

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
36 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 10, 2026

First Posted

August 14, 2026

Study Start (Estimated)

September 15, 2026

Primary Completion (Estimated)

June 30, 2029

Study Completion (Estimated)

June 30, 2029

Last Updated

August 14, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Individual participant data (IPD) will not be made publicly available. The study protocol does not include a formal data-sharing plan, and participant-level data are protected by applicable privacy and data protection regulations. Any potential future requests for access to study data will be considered on a case-by-case basis by the Sponsor and Investigator, subject to ethical, legal, and regulatory requirements.