Evaluating the GAAD score's effectiveness in detecting liver cancer in patients with chronic liver disease.
Addition of GAAD Score to Imaging Surveillance for Early Identification of Liver Cancer.
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 |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Erasmus Medical Center Academic / other |
| Locations | 1 site (Rotterdam, CA) |
| Trial ID | NCT06601231 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include patients with cirrhosis or non-cirrhotic chronic hepatitis B, C, or NASH with significant fibrosis.
Not a fit: Patients with other cancers, a history of HCC, or those unable to undergo necessary imaging will not benefit from this study.
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 performed: While the GAAD score's application in this context is relatively novel, similar studies have shown promise in improving cancer detection rates.
Eligibility criteria
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 this trial is running
Rotterdam, CA
- 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
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.