Clinical trial · Observational
HCC Screening Using DNA Methylation Changes in ctDNA
Clinical Trials on Detection of Hepatocellular Carcinoma With Non-invasive Method Based on DNA Methylation of Circulated Tumor DNA, PBMC and T Cells
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Hepatocellular Carcinoma (HCC) is the fifth most common cancer world-wide. It is particularly prevalent in Asia, and its occurrence is highest in areas where hepatitis B is prevalent, indicating a possible causal relationship. Follow up of high-risk populations such as chronic hepatitis patients and early diagnosis of transitions from chronic hepatitis to HCC would improve cure rates. In most cases HCC is detected late resulting in increased mortality and morbidity. The purpose of this study is to develop and test non-invasive biomarkers based on methylation changes in PBMC and circulated tumor DNA in hepatocellular carcinomas patients.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ctDNA methylation in and it's Correlation wth Development and prediction of HCC | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- chronic hepatitis B
- description
- This group will include 50 with hepatitis B subjects and the diagnoses will be based on AASLD practice guideline.
- interventionNames
- Diagnostic Test: ctDNA methylation in and it's Correlation wth Development and prediction of HCC
- label
- HCC Cases
- description
- This group will include 350 in stage 0, stage A, stage B, Stage C+D of hepatocellular carcinoma. HCC staging will be diagnosed according to EASL-EORTC Clinical Practice Guidelines: Management of hepatocellular carcinoma
- interventionNames
- Diagnostic Test: ctDNA methylation in and it's Correlation wth Development and prediction of HCC
- label
- Healthy
- description
- This group will include 50 healthy sex and age matched controls.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Confirmed diagnosis of HCC by EASL-EORTC guidelines * Confirmed hepatitis B diagnosis for HepB patients using AASLD practice guidelines. Exclusion Criteria for HCC: * Cirrhosis, any other known inflammatory disease (bacterial or viral infection with the exception of hepatitis B or C, diabetes, asthma, autoimmune disease, active thyroid disease) which could alter T cells and monocytes characteristics * Other cancers. Exclusion Criteria for HepB: * Diagnosis of HCC or any other cancer. Exclusion Criteria for Healthy Controls: * Any known inflammatory or infectious disease including HepB and HepC * Chronic diseases, * Cancer * Medications or drug use
References
Publications (0)
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