Clinical trial · Observational
Decoding Epigenetic Mechanisms Driving Immune Evasion in Liver Cancer With Omics Approaches
NCT07432347CI-TRIAL-00104255DELIVERrecruitingClinicalTrials.gov clinicaltrialsProvenance
- 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)
This is a national, observational, retrospective, cross-sectional, non-profit study focused on patients with HCC. The study aims to characterize the expression and function of novel noncoding regulatory transcripts, including those containing TEsin the microenvironment of liver tumors, with emphasis on their role in T cell dysfunction.
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 |
|---|---|---|---|
| Hepatocarcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Collection of tumor tissue (Fresh or/and archival FFPE), blood samples | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- HCC patients
- description
- 120 patients will be prospectively recruitedand from whom fresh tumor samples and blood samples will be collected. 150 HCC patients treated by surgery FFPE samples will be retrospectively collected
- interventionNames
- Genetic: Collection of tumor tissue (Fresh or/and archival FFPE), blood samples
Primary outcomes (1)
- measure
- Characterize the molecular mechanisms underlying T cell dysfunction
- timeFrame
- 5 years
- description
- To characterize the molecular mechanisms underlying T cell dysfunction and immune evasion in the tumor microenvironment of hepatocellular carcinoma, through the identification and functional definition of novel non-coding regulatory transcripts - including those containing transposable elements - expressed at single-cell resolution. Identification of TE-containing transcripts expressed in tumor-infiltrating lymphocytes (TILs) and other cellular populations within the HCC tumor microenvironment, using single-cell transcriptomics (scRNA-seq) and spatial transcriptomics technologies.
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
1. Histological/radiological (LR-4 o 5)diagnosis of hepatocellular carcinoma (HCC). 2. Solid tumor fresh tissue availability from HCC biospy or surgical resectionas per standard clinical practice, and/orHCC FFPE archival samples availability. 3. Capability of understanding and signing an inform consent form. 4. Known hepatits B and C status, including HBeAg (positive or negative), viral load (HBVDNA e HCV-RNA), HCV genotype, whether sustained virological response (SVR)was obtainedand potential antiviral treatments received (including direct antiretroviral therapy(DAA)and interferon). These parameters will be exploited to stratify patients and analyze the impact of the virological status on microenvironmental immunological features, with particular regards to immunesuppression mechanisms.
References
Publications (0)
Data not yet available
No reference posted for this study.