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CompletedNCT07872319Updated Oct 13, 2026

Biomarkers Usefulness in the Screening of Hepatocellular Carcinoma in an European High-risk Cohort.

An observational study in Hepatocellular Carcinoma (HCC), sponsored by Hospital Universitario La Paz. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-13.

Sponsored by Hospital Universitario La Paz · Observational

Updated Oct 13, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
417
Ages
18 Years and older
Sex
All
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Study 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 algorithms) in the screening of HCC.

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Conditions studied

  • Hepatocellular Carcinoma (HCC)

Keywords

  • hepatocellular carcinoma
  • tumour biomarkers
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In context

Carcinoma, Hepatocellular

3,251 studies on the registry are indexed under Carcinoma, Hepatocellular; 974 are open to participants now.

This study's enrollment of 417 is above the median of 200 across 769 observational studies indexed under Carcinoma, Hepatocellular.

Browse Carcinoma, Hepatocellular studies →

Lead sponsor

Hospital Universitario La Paz is the lead sponsor of 55 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients will be selected from among all those who come in for a liver ultrasound according to EASL recommendations of HCC surveillance

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Informed consent signed
  • EASL recommendations of HCC surveillance

Exclusion criteria

Exclusion Criteria:

  • 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.
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
417 participants (actual)
Target follow-up
2 Years
Patient registry
Yes

Groups and cohorts

  • 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.

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What researchers measure

Primary outcomes

  1. Alpha-fetoprotein (AFP)

    tumour biomarkers measured by blood test

    Time frame: Every 6 motnhs

07

Study locations

1 site
  • Hospital Universitario La Paz
    Madrid, 28046, Spain
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References and documents

Individual participant data

Plan to share: 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).

No publications or documents are linked to this record.

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Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 13, 2026
Show all 1 update
  1. Oct 13, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

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Registry details

Key details

Study ID
NCT07872319
Lead sponsor
Hospital Universitario La Paz
Responsible party
María Dolores Martín Arranz, PhD (Dr, Hospital Universitario La Paz) — Principal investigator
First posted
Oct 13, 2026
Start date
Feb 2, 2022
Primary completion
Jul 31, 2025
Completion
Jul 31, 2025
Last update
Oct 13, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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