Clinical trial · Observational
Characterization of Methylation Patterns in Hepatocellular Carcinoma
NCT04264754CI-TRIAL-00051647terminatedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Sponsor prioritize other clinical projects over this study
Summary
Brief summary (as posted)
This study is being performed as part of the development process of the Liver EpiCheck test which includes the identification of different methylation profiles in HCC (hepatocellular carcinoma) patients compare to cancer free control in blood samples
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cirrhosis | — | UNRESOLVED | — |
| Hepatocellular Cancer | Hepatocellular Carcinoma | CURATED_BROADER | 0.80 |
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood collection | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Cases Group
- description
- Subjects who have already been diagnosed with liver cancer, however did not yet undergo any surgery, ablation, embolization or any other treatment for this cancerous lesion (including, but not limited to systemic therapies)
- interventionNames
- Procedure: Blood collection
- label
- Control Group
- description
- Cancer free subjects with high risk to development HCC. High risk subjects include the following: 1. Subjects with HCV (hepatitis C virus) and cirrhosis 2. Subjects with HBV (hepatitis B virus) and cirrhosis 3. Non-cirrhotic chronic HBV subjects at intermediate or high risk of HCC, according to EASL (European Association for the Study of the Liver) Clinical Practice Guidelines for the management of hepatocellular carcinoma 4. Subjects with NAFLD (Non-Alcoholic Fatty Liver Disease) with cirrhosis 5. Cirrhotic patients due to any other reasons, including alcohol disease
- interventionNames
- Procedure: Blood collection
Primary outcomes (2)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 22 Years
Show eligibility criteria text
Inclusion Criteria - Case Group: * Age ≥ 22 years * Subjects who are willing and able to provide written informed consent * Subjects with confirmed diagnosis of HCC, naïve to tumor directed therapy Exclusion Criteria - Case Group: * Subjects with current cancer of any kind, other than hepatocellular carcinoma * Subjects with a history of cancer of any kind (including hepatocellular carcinoma), other than non-melanoma skin cancer completely resected * Coinfection with HIV * Prior solid organ transplant Inclusion Criteria - Control Group: * Age ≥ 22 years * Subjects who are willing and able to provide written informed consent * Subjects diagnosed with one of the following: i. Subjects with HCV and cirrhosis ii. Subjects with HBV and cirrhosis iii. Non-cirrhotic chronic HBV subjects at intermediate or high risk of HCC, according to EASL Clinical Practice Guidelines for the management of hepatocellular carcinoma iv. Subjects with Non-Alcoholic Fatty Liver Disease (NAFLD) with cirrhosis. v. Cirrhotic patients due to any other reasons, including alcohol disease * Subjects currently undergoing surveillance for hepatocellular carcinoma * HCC surveillance imaging (e.g., US, CT, MRI) performed within 3 months prior to baseline visit * Subjects with compensated liver function as measured by Child-Pugh Score A or B7 without ascites (all measures should be from the last three months) Exclusion Criteria - Control Group: * Subjects with current cancer of any kind, other than hepatocellular carcinoma * Subjects with a history of cancer of any kind (including hepatocellular carcinoma), other than non-melanoma skin cancer completely resected * Coinfection with HIV * Prior solid organ transplant * Current substance abuse
References
Publications (0)
Data not yet available
No reference posted for this study.