Mapping epigenetic changes that help liver cancer evade the immune system using detailed molecular profiling.
Official title: Decoding Epigenetic Mechanisms Driving Immune Evasion in Liver Cancer With Omics Approaches
Run by Niguarda Hospital · NCT07432347 · Data updated 2026-11-12
This project will use tumor and blood samples from people with hepatocellular carcinoma to see if specific noncoding RNAs and epigenetic changes are linked to T cell dysfunction in tumors.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 270 (estimated) |
| Sponsor | Niguarda Hospital Academic / other |
| Locations | 1 site (Milan, Lombardy) |
| Status | Recruiting |
| Started | January 1, 2026 |
| Main results expected | January 31, 2029 |
| Study ends | January 31, 2031 |
| Registry record updated | February 27, 2026 |
| Trial ID | NCT07432347 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with a confirmed radiologic or histologic diagnosis of hepatocellular carcinoma who can provide fresh tumor tissue or archival FFPE samples and blood, know their HBV/HCV status, and can give informed consent.
✕Probably not a fit
People without available tumor tissue or blood samples, those who cannot consent, or those seeking immediate treatment changes are unlikely to receive direct clinical benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The study will analyze tumor-infiltrating lymphocytes and other immune, hepatocyte, and stromal cells from HCC tissue, matched adjacent non-tumoral liver, and blood using single-cell RNA sequencing and spatial transcriptomics to map where TE-containing and other noncoding transcripts are expressed. Epigenetic assays including ChIP-seq, ATAC-seq, DNA methylation profiling, RADICL-seq, and Hi-C will be used to define chromatin architecture and regulatory networks associated with these transcripts. Functional perturbations using CRISPR-Cas13 or antisense oligonucleotides will test whether specific noncoding transcripts modulate cellular identity and T cell dysfunction. The study is a national, retrospective, cross-sectional observational project using fresh or archival FFPE tumor tissue and matched blood samples.
Why it matters
Potential benefit: If successful, the work could identify new biomarkers or therapeutic targets to restore T cell function and improve immunotherapy outcomes for people with HCC.
How similar studies have gone: Single-cell and epigenetic multi-omics approaches have successfully revealed immune-tumor interactions in several cancers and some HCC studies, but focusing on TE-containing noncoding transcripts in T cell dysfunction is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
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ASST GOM Niguarda
Milan, Lombardy, Italy Recruiting
Study contacts
- Principal investigator: Gianluca Mauri, MD — ASST Grande Ospedale Metropolitano Niguarda
- Study coordinator: Gianluca Mauri, MD
- Email: gianluca.mauri@ospedaleniguarda.it
- Phone: +39026444
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.