Evaluating the GAAD score's effectiveness in detecting liver cancer in patients with chronic liver disease.
Official title: Addition of GAAD Score to Imaging Surveillance for Early Identification of Liver Cancer.
Run by Erasmus Medical Center · NCT06601231 · Data updated 2026-11-12
This study is testing if the GAAD score can help find liver cancer earlier in people with chronic liver disease who need regular check-ups.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 1000 (estimated) |
| Sponsor | Erasmus Medical Center Academic / other |
| Locations | 1 site (Rotterdam, CA) |
| Status | Recruiting |
| Started | March 18, 2024 |
| Main results expected | April 18, 2027 |
| Study ends | July 2027 |
| Registry record updated | September 19, 2024 |
| Trial ID | NCT06601231 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include patients with cirrhosis or non-cirrhotic chronic hepatitis B, C, or NASH with significant fibrosis.
✕Probably not a fit
Patients with other cancers, a history of HCC, or those unable to undergo necessary imaging will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to assess the impact of the GAAD score in conjunction with imaging techniques for patients with chronic liver disease who are eligible for hepatocellular carcinoma (HCC) surveillance. It will evaluate the diagnostic accuracy of the GAAD score for detecting HCC, including its sensitivity and specificity, and track changes in the GAAD score over time. A total of 1000 participants will be enrolled, and data will be collected over three years, with bi-annual imaging and GAAD score assessments performed as part of standard clinical practice.
Why it matters
Potential benefit: If successful, this study could enhance early detection of hepatocellular carcinoma in at-risk patients, potentially improving treatment outcomes.
How similar studies have gone: While the GAAD score's application in this context is relatively novel, similar studies have shown promise in improving cancer detection rates.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * All patients with cirrhosis * Non-cirrhotic chronic hepatitis B patients meeting any of the following criteria: positive family history for HCC, intermediate-high aMAP and/or (m)PAGE-B score (if non-Caucasian) * Non-cirrhotic chronic hepatitis C patients (with or without SVR) with a history of F3 fibrosis (based on histology or liver stiffness assessment) * Non-cirrhotic NASH patients with a history of F3 fibrosis (based on histology or liver stiffness assessment) Exclusion Criteria: * Diagnosis with any other cancer other than non-melanoma skin cancer * History of HCC * Women who are pregnant or lactating * Patient with glomerular filtration rate \<45 ml /min/1.73 m2 * Unwillingness or inability to undergo both CT and MRI imaging * Life expectancy \<2 years * Use of vitamin K antagonists
Where it's running
-
Erasmus MC
Rotterdam, Ca, Netherlands Recruiting
Study contacts
- Principal investigator: M. J. Sonneveld, MD, PhD — Erasmus Medical Center
- Study coordinator: Mohamed Moussa, MD
- Email: m.moussa@erasmusmc.nl
- Phone: 0685529560
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.