HepatocarcinomaDELIVERNCT07432347
Decoding Epigenetic Mechanisms Driving Immune Evasion in Liver Cancer With Omics Approaches
An observational study of Hepatocarcinoma, run by Niguarda Hospital at 1 site in Italy.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocarcinoma
- What is being tested?
- Collection of tumor tissue (Fresh or/and archival FFPE), blood samples
- How many people
- 270 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2026to 31 Jan 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with HCC and eligible for biopsy or surgical resection
- Histological/radiological (LR-4 o 5)diagnosis of hepatocellular carcinoma (HCC).
- Solid tumor fresh tissue availability from HCC biospy or surgical resectionas per standard clinical practice, and/orHCC FFPE archival samples availability.
- Capability of understanding and signing an inform consent form.
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
ASST GOM Niguarda
Milan, Lombardy, 20162
Gianluca Mauri, MD, +39026444 ext. 3695, gianluca.mauri@ospedaleniguarda.it
About this study
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.
Read the detailed description
We will use TILs, along with other immune, hepatocyte, and stromal cell populations isolated from hepatocellular carcinoma (HCC) tissue, matched adjacent non-tumoral liver, and peripheral blood samples. Single-cell RNA sequencing and spatial transcriptomics will be employed to define the cellular distribution and molecular profiles of TE-containing transcripts, other noncoding RNAs, and associated gene expression programs within the HCC microenvironment. Functional experiments-including CRISPR-Cas13 or ASO-mediated silencing-will be performed to elucidate the role of the novel regulatory transcripts, including TE-transcripts, in modulating cellular identity within the liver TME. In parallel, epigenetic analyses such as ChIPseq, ATAC-seq, DNA methylation profiling, RADICL-seq, and Hi-C will be conducted to map the regulatory networks and chromatin architecture associated with these transcripts
- Conditions
- Hepatocarcinoma
- Being tested
- Collection of tumor tissue (Fresh or/and archival FFPE), blood samples
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collection of tumor tissue (Fresh or/and archival FFPE), blood samplesGenetic
NGS, immunofluorescence analyses, transcriptional and immunophenotypic analyzes, scRNAseq, ChIP-seq/ATAC-seq, DNA methylation, single-cell transcriptomic and TCR sequencing
| Study group | Role | What they receive |
|---|---|---|
| HCC patients | 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 Receives: Genetic: Collection of tumor tissue (Fresh or/and archival FFPE), blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterize the molecular mechanisms underlying T cell dysfunction
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.
Measured: 5 years
Secondary outcomes (2)
Analyze the epigenetic transcriptional regulatory mechanisms
To analyze the epigenetic and transcriptional regulatory mechanisms mediated by the newly identified transcripts from the primary objective, including TEcontaining transcripts, in the cellular components of the HCC tumor microenvironment. Mapping of the genomic occupancy, epigenetic landscape, and three-dimensional chromatin conformation associated with the newly identified regulatory transcripts, including those containing TEs, in TME cells, with particular attention to TILs.
Measured: 5 years
Retrospective analysis on FFPE samples
Evaluation of the expression dynamics of regulatory transcripts, including those containing TEs, as potential predictive biomarkers of response to immunotherapy, through retrospective analysis on FFPE tissue samples.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2026
- Study start1 Jan 2026
- Primary completion31 Jan 2029 (estimated)
- Study completion31 Jan 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HepatocarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Niguarda Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- San Raffaele University Hospital, Italy, Fondazione Istituto Nazionale Genetica Molecolare - INGM, University of Milan
- Responsible party
- Sponsor
- Investigators
- Gianluca Mauri, MD, Principal investigator, ASST Grande Ospedale Metropolitano Niguarda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07432347
- Sponsor's protocol ID
- 6605
- Acronym
- DELIVER
- Status last verified
- Feb 2026
- First submitted
- 19 Feb 2026
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Not yet decided
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decoding Epigenetic Mechanisms Driving Immune Evasion in Liver Cancer With Omics Approaches
- ClinicalTrials.gov ID
- NCT07432347
- Acronym / sponsor ID
- DELIVER / 6605
- Conditions
- Hepatocarcinoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- Niguarda HospitalUniversity, hospital or other
- Collaborators
- San Raffaele University Hospital, Italy, Fondazione Istituto Nazionale Genetica Molecolare - INGM, University of Milan
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 31 Jan 2029 (estimated)
- Study completion
- 31 Jan 2031 (estimated)
- First posted
- 25 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
We will use TILs, along with other immune, hepatocyte, and stromal cell populations isolated from hepatocellular carcinoma (HCC) tissue, matched adjacent non-tumoral liver, and peripheral blood samples. Single-cell RNA sequencing and spatial transcriptomics will be employed to define the cellular distribution and molecular profiles of TE-containing transcripts, other noncoding RNAs, and associated gene expression programs within the HCC microenvironment. Functional experiments-including CRISPR-Cas13 or ASO-mediated silencing-will be performed to elucidate the role of the novel regulatory transcripts, including TE-transcripts, in modulating cellular identity within the liver TME. In parallel, epigenetic analyses such as ChIPseq, ATAC-seq, DNA methylation profiling, RADICL-seq, and Hi-C will be conducted to map the regulatory networks and chromatin architecture associated with these transcripts
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HCC patients | – | Genetic: Collection of tumor tissue (Fresh or/and archival FFPE), blood samples120 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with HCC and eligible for biopsy or surgical resection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collection of tumor tissue (Fresh or/and archival FFPE), blood samplesNGS, immunofluorescence analyses, transcriptional and immunophenotypic analyzes, scRNAseq, ChIP-seq/ATAC-seq, DNA methylation, single-cell transcriptomic and TCR sequencing | Genetic | HCC patients |
Primary outcome
Characterize the molecular mechanisms underlying T cell dysfunction
Time frame: 5 years
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.
2 secondary outcomes
Analyze the epigenetic transcriptional regulatory mechanisms
Time frame: 5 years
Retrospective analysis on FFPE samples
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Individual participant dataSharing planned: Undecided. Not yet decided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gianluca Mauri, MD principal investigator
ASST Grande Ospedale Metropolitano Niguarda
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocarcinoma, run by Niguarda Hospital at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gianluca Mauri, MD (+39026444 ext. 3695, gianluca.mauri@ospedaleniguarda.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characterize the molecular mechanisms underlying T cell dysfunction (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.