Using blood biomarkers to diagnose liver cancer early
Use of Blood Biomarkers for the Early Diagnosis of Hepatocellular Carcinoma (HCC)
This study is testing if certain blood tests can help find liver cancer earlier in patients who are at high risk due to chronic liver disease.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Sex | All |
| Sponsor | Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis Academic / other |
| Locations | 1 site (Castellana Grotte, Bari) |
| Trial ID | NCT05781568 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the effectiveness of three blood biomarkers—α-FP, α-FP-L3, and DCP—in predicting hepatocellular carcinoma (HCC) in high-risk patients. It aims to assess the performance of GALAD and GALADUS scores for early diagnosis and to explore the relationship between biomarker levels and HCC stages. The study focuses on patients with chronic liver disease, particularly those with cirrhosis and chronic hepatitis, to improve early detection rates of HCC.
Who should consider this trial
Good fit: Ideal candidates include patients with liver cirrhosis or chronic hepatitis who are at high risk for developing HCC.
Not a fit: Patients who have been treated with anticoagulants like Warfarin may not benefit due to the potential for false positive results.
Why it matters
Potential benefit: If successful, this study could lead to earlier diagnosis of hepatocellular carcinoma, improving treatment outcomes and survival rates for patients.
How similar studies have performed: Other studies have shown promise in using blood biomarkers for early detection of liver cancer, indicating that this approach has potential based on previous findings.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Case Group: * Patients with HCC first diagnosed from cirrhosis or other aetiology 2. Controls group: * Candidate patients for HCC surveillance, with liver cirrhosis and chronic hepatitis of any etiology without HCC seen at our institution Exclusion Criteria: * Patients treated with Warfarin, an anticoagulant, as it can increase DCP levels in the absence of HCC, risking giving false positives
Where this trial is running
Castellana Grotte, Bari
- RCCS "Saverio de Bellis" — Castellana Grotte, Bari, Italy (Recruiting)
Study contacts
- Principal investigator: Endrit Shahini, MD — IRCCS "Saverio de Bellis" - Castellana Grotte (BA) - Italy
- Study coordinator: Endrit Shahini, MD
- Email: endrit.shahini@irccsdebellis.it
- Phone: 00390804994249
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.