Hepatocellular Carcinoma (HCC)NCT07872319
Biomarkers Usefulness in the Screening of Hepatocellular Carcinoma in an European High-risk Cohort.
An observational study of Hepatocellular Carcinoma (HCC), run by Hospital Universitario La Paz at 1 site in Spain.
Trial summary
Longitudinal, prospective, observational, non-interventional study, to evaluate the performance of tumour biomarkers Alpha-fetoprotein (AFP), Lens culinaris-agglutinin-reactive fraction of AFP (AFP-L3), and protein induced by vitamin K absence or antagonist-II (PIVKA-II) and their combinations (GAAD and GALAD… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma (HCC)
- How many people
- 417 participants
- Where
- 1 siteSpain
- Study dates
- 2 Feb 2022to 31 Jul 2025
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Patients will be selected from among all those who come in for a liver ultrasound according to EASL recommendations of HCC surveillance
Who may be able to join
- Informed consent signed
- EASL recommendations of HCC surveillance
Who cannot join
- Child-Pugh C class (except liver transplant eligibility).
- Pregnancy, past or present germ cell tumours, obstructive jaundice, intrahepatic cholestasis causing chronic decrease in vitamin K.
- Ingestion of drugs such as warfarin or medications containing vitamin K preparations.
Trial locations and contacts
1 site in 1 country.
About this study
Longitudinal, prospective, observational, non-interventional study, to evaluate the performance of tumour biomarkers Alpha-fetoprotein (AFP), Lens culinaris-agglutinin-reactive fraction of AFP (AFP-L3), and protein induced by vitamin K absence or antagonist-II (PIVKA-II) and their combinations (GAAD and GALAD algorithms) in the screening of HCC.
- Conditions
- Hepatocellular Carcinoma (HCC)
- Keywords
- hepatocellular carcinoma, tumour biomarkers
- Medical subject headings
- Carcinoma, Hepatocellular
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 |
|---|---|---|
| Case patients | US imaging of the liver will be performed with grayscale and colour Doppler US in transverse and longitudinal views, taking care to depict the entire liver. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alpha-fetoprotein (AFP)
tumour biomarkers measured by blood test
Measured: Every 6 motnhs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2026
- Study start2 Feb 2022
- Primary completion31 Jul 2025
- Study completion31 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular Carcinoma (HCC)Studies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 417 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Hospital Universitario La Paz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, María Dolores Martín Arranz, PhD, Hospital Universitario La Paz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07872319
- Sponsor's protocol ID
- PI-5247
- Status last verified
- Oct 2026
- First submitted
- 7 Oct 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The results of the clinical study will be documented in a clinical study report and if possible, will be published (e.g. in a journal or presented in a scientific meeting).
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarkers Usefulness in the Screening of Hepatocellular Carcinoma in an European High-risk Cohort.
- ClinicalTrials.gov ID
- NCT07872319
- Acronym / sponsor ID
- PI-5247
- Conditions
- Hepatocellular Carcinoma (HCC)
- Keywords
- hepatocellular carcinoma, tumour biomarkers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 417 participants (actual)
- Lead sponsor
- Hospital Universitario La PazUniversity, hospital or other
- Study start
- 2 Feb 2022 (actual)
- Primary completion
- 31 Jul 2025 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 13 Oct 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.
Longitudinal, prospective, observational, non-interventional study, to evaluate the performance of tumour biomarkers Alpha-fetoprotein (AFP), Lens culinaris-agglutinin-reactive fraction of AFP (AFP-L3), and protein induced by vitamin K absence or antagonist-II (PIVKA-II) and their combinations (GAAD and GALAD algorithms) in the screening of HCC.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Case patients | – | –US imaging of the liver will be performed with grayscale and colour Doppler US in transverse and longitudinal views, taking care to depict the entire liver. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be selected from among all those who come in for a liver ultrasound according to EASL recommendations of HCC surveillance
Key inclusion criteria (2 listed)
- Informed consent signed
- EASL recommendations of HCC surveillance
Key exclusion criteria (3 listed)
- Child-Pugh C class (except liver transplant eligibility).
- Pregnancy, past or present germ cell tumours, obstructive jaundice, intrahepatic cholestasis causing chronic decrease in vitamin K.
- Ingestion of drugs such as warfarin or medications containing vitamin K preparations.
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
Alpha-fetoprotein (AFP)
Time frame: Every 6 motnhs
tumour biomarkers measured by blood test
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: Yes. The results of the clinical study will be documented in a clinical study report and if possible, will be published (e.g. in a journal or presented in a scientific meeting).
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocellular Carcinoma (HCC), run by Hospital Universitario La Paz at 1 site in Spain.
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 2 inclusion and 3 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: finished, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alpha-fetoprotein (AFP) (time frame: Every 6 motnhs). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Oct 2026.