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| ID | Type | Description | Link |
|---|---|---|---|
| CIV-23-08-043855 | Other Identifier | Swedish Medical Products Agency |
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| Name | Class |
|---|---|
| Antaros Medical | INDUSTRY |
| Amra Medical AB | INDUSTRY |
| Region Östergötland | OTHER |
| Region Jönköping County |
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DETECT-HCC-ESLD is a prospective multicenter study designed to examine early detection and risk stratification of hepatocellular carcinoma (HCC) in individuals with advanced liver disease. Adults with cirrhosis of different etiologies are enrolled and followed longitudinally with structured clinical assessments and imaging at predefined intervals.
A key objective is to evaluate ultrasound and abbreviated MRI (AMRI) as surveillance modalities for HCC. The study examines detection performance, feasibility, and factors influencing image quality and interpretability.
The protocol also includes the study of body composition, focusing on how variations in adiposity and muscle mass may relate to imaging characteristics, disease progression, and HCC risk.
Longitudinal clinical and imaging data are used to explore prediction models aimed at identifying patients with differing levels of HCC risk. The study records outcomes such as incident HCC, liver-related complications, and mortality to support analyses of disease trajectories.
The DETECT-HCC-ESLD study provides a structured framework for collecting clinical, imaging, and body composition data over time, enabling detailed evaluation of surveillance strategies and risk patterns in advanced liver disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adult patients with liver cirrhosis without prior hepatocellular carcinoma |
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| Measure | Description | Time Frame |
|---|---|---|
| Lesion at high risk for hepatocellular carcinoma (HCC) - (LI RADS 4-5) | A nodule on MRI classified as LI-RADS 4 or 5 according to the American College of Radiology (ACR) LI-RADS criteria. | Baseline visit |
| Lesion at high risk for hepatocellular carcinoma (HCC) - (LI RADS 4-5) | A nodule on MRI classified as LI-RADS 4 or 5 according to the American College of Radiology (ACR) LI-RADS criteria. | Visit 2 (6 months) |
| Lesion at high risk for hepatocellular carcinoma (HCC) - (LI RADS 4-5) | A nodule on MRI classified as LI-RADS 4 or 5 according to the American College of Radiology (ACR) LI-RADS criteria. | Visit 3 (12 months) |
| Lesion at high risk for hepatocellular carcinoma (HCC) - (LI RADS 4-5) | A nodule on MRI classified as LI-RADS 4 or 5 according to the American College of Radiology (ACR) LI-RADS criteria. | Visit 4 (18 months) |
| Lesion at high risk for hepatocellular carcinoma (HCC) - (US LI RADS 3) | A nodule on ultrasound classified as US LI-RADS 3 according to the American College of Radiology (ACR) LI-RADS criteria | Baseline visit |
| Lesion at high risk for hepatocellular carcinoma (HCC) - (US LI RADS 3) | A nodule on ultrasound classified as US LI-RADS 3 according to the American College of Radiology (ACR) LI-RADS criteria | Visit 2 (6 months) |
| Lesion at high risk for hepatocellular carcinoma (HCC) - (US LI RADS 3) |
| Measure | Description | Time Frame |
|---|---|---|
| Hepatocellular carcinoma (HCC) | HCC verified by pathology. | From enrollment and six months after last visit (a total of 24 months). |
| Treatment for hepatocellular carcinoma | Treatment given to patients that develope HCC: ablation, resection, TACE, systemic treatment, or best supportive care. |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients with liver cirrhosis without prior hepatocellular carcinoma or liver transplant.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mattias Ekstedt, MD, PhD | Contact | 0046709296267 | mattias.ekstedt@liu.se |
| Name | Affiliation | Role |
|---|---|---|
| Mattias Ekstedt, MD, PhD | Linkoeping University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of gastroenterology and hepatology, University hospital in Linköping | Recruiting | Linköping | Select A State Or Province | S-58931 | Sweden |
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| OTHER_GOV |
| Västra Götalandsregionen | OTHER |
| Region Stockholm | OTHER_GOV |
| Örebro County Council | OTHER_GOV |
| Uppsala County Council, Sweden | OTHER_GOV |
| University Hospital, Umeå | OTHER |
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Serum, plasma, whole blood, liver biopsy.
A nodule on ultrasound classified as US LI-RADS 3 according to the American College of Radiology (ACR) LI-RADS criteria |
| Visit 3 (12 months) |
| Lesion at high risk for hepatocellular carcinoma (HCC) - (US LI RADS 3) | A nodule on ultrasound classified as US LI-RADS 3 according to the American College of Radiology (ACR) LI-RADS criteria | Visit 4 (18 months) |
| The Muscle Assessment Score (MAsS) | The Muscle Assessment Score (MAsS) combines thigh muscle z-score and muscle fat infiltration to detect muscle composition phenotypes. | Baseline visit |
| The Muscle Assessment Score (MAsS) | The Muscle Assessment Score (MAsS) combines thigh muscle z-score and muscle fat infiltration to detect muscle composition phenotypes. | Visit 2 (12 months) |
| The Muscle Assessment Score (MAsS) | The Muscle Assessment Score (MAsS) combines thigh muscle z-score and muscle fat infiltration to detect muscle composition phenotypes. | Visit 3 (12 months) |
| The Muscle Assessment Score (MAsS) | The Muscle Assessment Score (MAsS) combines thigh muscle z-score and muscle fat infiltration to detect muscle composition phenotypes. | Visit 4 (18 months) |
| Liver associated clinical events (LACE) | Any of clinical ascites, variceal bleeding, hepatic encephalopathy west haven >= grade 2, hepatorenal syndrome, or hepatopulmonary syndrome. | From enrollment and six months after the last study visit (after a total of 24 months). |
| From enrollment and six months after last visit (a total of 24 months). |
| Death | All cause mortality | From enrollment and six months after last visit (a total of 24 months). |
| Liver stiffness (VCTE) | Liver stiffness measured with Fibroscan | Baseline |
| Liver stiffness (VCTE) | Liver stiffness measured with Fibroscan | Visit 2 (6 months) |
| Liver stiffness (VCTE) | Liver stiffness measured with Fibroscan | Visit 3 (12 months) |
| Liver stiffness (VCTE) | Liver stiffness measured with Fibroscan | Visit 4 (18 months) |
| Liver stiffness (MRE) | Liver stiffness measured with magnetic resonance elastography (MRE) | Baseline |
| Liver stiffness (MRE) | Liver stiffness measured with magnetic resonance elastography (MRE) | Visit 2 (6 months) |
| Liver stiffness (MRE) | Liver stiffness measured with magnetic resonance elastography (MRE) | Visit 3 (12 months) |
| Liver stiffness (MRE) | Liver stiffness measured with magnetic resonance elastography (MRE) | Visit 4 (18 months) |
| Liver volume | Liver volume measured with MRI | Baseline |
| Liver volume | Liver volume measured with MRI | Visit 2 (6 months) |
| Liver volume | Liver volume measured with MRI | Visit 3 (12 months) |
| Liver volume | Liver volume measured with MRI | Visit 4 (18 months) |
| Spleen volume | Spleen volume measured with MRI | Baseline |
| Spleen volume | Spleen volume measured with MRI | Visit 2 (6 months) |
| Spleen volume | Spleen volume measured with MRI | Visit 3 (12 months) |
| Spleen volume | Spleen volume measured with MRI | Visit 4 (18 months) |
| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| D008103 | Liver Cirrhosis |
| D055948 | Sarcopenia |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D012816 | Signs and Symptoms |
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