Hepatocellular CarcinomaScreening HCCNCT07764835
Prospective Evaluation of Hepatocellular Carcinoma Surveillance in At-Risk Patients (Screening HCC)
An observational study of Hepatocellular Carcinoma and Liver Cirrhosis, run by D'Or Institute for Research and Education.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma, Liver Cirrhosis, Chronic Hepatitis B
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 15 Sep 2026to 30 Jun 2029
- How long will I take part?
- 36 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Escritório O Operações contact
About this study
Official title: Prospective Evaluation of Hepatocellular Carcinoma Surveillance in At-Risk Patients Using Semiannual Ultrasound LI-RADS and Alpha-Fetoprotein: A Multicenter Real-World Observational Study
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.
Read the detailed description
Hepatocellular carcinoma (HCC) is the most common primary liver malignancy and remains a leading cause of cancer-related mortality worldwide. Early detection through surveillance is associated with improved access to curative therapies and better survival outcomes. Despite international guideline recommendations, implementation of surveillance programs remains heterogeneous in routine clinical practice, and limited real-world evidence is available regarding the effectiveness of structured HCC surveillance pathways in Brazil.
This prospective multicenter observational study is designed to evaluate the performance of a structured HCC surveillance program implemented within the Rede D'Or healthcare network. The program combines standardized abdominal ultrasound reporting using the Ultrasound Liver Imaging Reporting and Data System (US LI-RADS), regular alpha-fetoprotein (AFP) assessment, dedicated training of healthcare professionals, and predefined referral pathways for diagnostic evaluation and clinical management.
The study aims to generate real-world evidence regarding the effectiveness of standardized surveillance strategies in populations at increased risk for HCC. In addition to evaluating HCC detection, the study will assess the clinical characteristics and staging patterns of diagnosed tumors, detection of other malignant liver lesions, and the efficiency of the diagnostic and treatment pathway. Special attention will be given to patients who do not fully meet traditional surveillance criteria but may still present clinically relevant risk for HCC, including individuals with advanced fibrosis and metabolic dysfunction-associated steatotic liver disease (MASLD).
No experimental interventions will be administered as part of this protocol. All surveillance procedures, diagnostic investigations, and treatment decisions will be performed according to routine clinical practice and the judgment of treating physicians. Data generated during routine care will be collected prospectively and analyzed to better understand the effectiveness of structured surveillance programs in real-world clinical settings.
- Conditions
- Hepatocellular Carcinoma, Liver Cirrhosis, Chronic Hepatitis B, Metabolic Dysfunction-Associated Steatotic Liver Disease, Advanced Liver Fibrosis
- Keywords
- HCC, Hepatocellular Carcinoma, Liver Cancer, HCC Surveillance, US LI-RADS, Ultrasound LI-RADS, Alpha-Fetoprotein, AFP, Liver Cirrhosis, Chronic Hepatitis B, MASLD, Metabolic Dysfunction-Associated Steatotic Liver Disease, Real-World Study, Observational Study, Early Detection, BCLC, Rede D'Or, Brazil
- Medical subject headings
- Carcinoma, Hepatocellular, Liver Cirrhosis, Hepatitis B, Chronic, Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Annual Incidence Rate of Hepatocellular Carcinoma
Incidence of newly diagnosed hepatocellular carcinoma among participants enrolled in the structured surveillance program
Measured: Up to 36 months
Secondary outcomes (1)
Early-Stage HCC Detection Rate
Proportion of hepatocellular carcinoma cases diagnosed at BCLC stage 0 or A.
Measured: Up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2026
- Study start15 Sep 2026 (estimated)
- Primary completion30 Jun 2029 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 36 Months
Sponsor and investigators
- Lead sponsor
- D'Or Institute for Research and Education
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor
- Investigators
- Leonardo G Fonseca, MD, MSc, Principal investigator, D'Or Institute for Research and Education (IDOR)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07764835
- Sponsor's protocol ID
- D133FR00247
- Acronym
- Screening HCC
- Status last verified
- Aug 2026
- First submitted
- 10 Aug 2026
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 37348031European 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.
PubMed 39690085Singal 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.
PubMed 37199193Singal 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.
PubMed 35139400
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Hepatocellular Carcinoma Surveillance in At-Risk Patients Using Semiannual Ultrasound LI-RADS and Alpha-Fetoprotein: A Multicenter Real-World Observational Study
- ClinicalTrials.gov ID
- NCT07764835
- Acronym / sponsor ID
- Screening HCC / D133FR00247
- Conditions
- Hepatocellular Carcinoma, Liver Cirrhosis, Chronic Hepatitis B, Metabolic Dysfunction-Associated Steatotic Liver Disease, Advanced Liver Fibrosis
- Keywords
- HCC, Hepatocellular Carcinoma, Liver Cancer, HCC Surveillance, US LI-RADS, Ultrasound LI-RADS, Alpha-Fetoprotein, AFP
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- D'Or Institute for Research and EducationUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- 15 Sep 2026 (estimated)
- Primary completion
- 30 Jun 2029 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 14 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Hepatocellular carcinoma (HCC) is the most common primary liver malignancy and remains a leading cause of cancer-related mortality worldwide. Early detection through surveillance is associated with improved access to curative therapies and better survival outcomes. Despite international guideline recommendations, implementation of surveillance programs remains heterogeneous in routine clinical practice, and limited real-world evidence is available regarding the effectiveness of structured HCC surveillance pathways in Brazil.
This prospective multicenter observational study is designed to evaluate the performance of a structured HCC surveillance program implemented within the Rede D'Or healthcare network. The program combines standardized abdominal ultrasound reporting using the Ultrasound Liver Imaging Reporting and Data System (US LI-RADS), regular alpha-fetoprotein (AFP) assessment, dedicated training of healthcare professionals, and predefined referral pathways for diagnostic evaluation and clinical management.
The study aims to generate real-world evidence regarding the effectiveness of standardized surveillance strategies in populations at increased risk for HCC. In addition to evaluating HCC detection, the study will assess the clinical characteristics and staging patterns of diagnosed tumors, detection of other malignant liver lesions, and the efficiency of the diagnostic and treatment pathway. Special attention will be given to patients who do not fully meet traditional surveillance criteria but may still present clinically relevant risk for HCC, including individuals with advanced fibrosis and metabolic dysfunction-associated steatotic liver disease (MASLD).
No experimental interventions will be administered as part of this protocol. All surveillance procedures, diagnostic investigations, and treatment decisions will be performed according to routine clinical practice and the judgment of treating physicians. Data generated during routine care will be collected prospectively and analyzed to better understand the effectiveness of structured surveillance programs in real-world clinical settings.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 36 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Annual Incidence Rate of Hepatocellular Carcinoma
Time frame: Up to 36 months
Incidence of newly diagnosed hepatocellular carcinoma among participants enrolled in the structured surveillance program
1 secondary outcome
Early-Stage HCC Detection Rate
Time frame: Up to 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
- Background: PubMed 37348031Fonseca 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.
- Background: PubMed 39690085European 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.
- Background: PubMed 37199193Singal 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.
- Background: PubMed 35139400Singal 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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Escritório O Operações contact
Leonardo G Fonseca, MD, MSc principal investigator
D'Or Institute for Research and Education (IDOR)
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocellular Carcinoma and Liver Cirrhosis, run by D'Or Institute for Research and Education.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Guilherme C Ambrósio, MSc (+55 11 972763211, guilherme.ambrosio@idor.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Annual Incidence Rate of Hepatocellular Carcinoma (time frame: Up to 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07764835, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2026.