Hepatocellular CarcinomaNCT06905262
Tumor Antigen Discovery for Innovative Cancer Immunotherapies in HCC: from Benchside to Bedside (HepAnt)
An observational study of Hepatocellular Carcinoma, run by National Cancer Institute, Naples at 1 site in Italy.
Trial summary
Tumor Antigen Discovery for Innovative Cancer Immunotherapies in HCC: From Benchside to Bedside (HepAnt) - Study of the Role of the Metagenome in Head and Neck Tumors Using Omics Techniques (HeNomics). Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Hepatocellular Carcinoma
- How many people
- 70 participants
- Where
- 1 siteItaly
- Study dates
- 2 Jan 2023to 30 Sep 2025
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: * Patients with primary hepatocellular carcinoma attending the Institute for medical/surgical treatment (surgery, locoregional treatments, systemic pharmacological treatments). In addition, patients with a diagnosis of oncological pathology attending the Institute will be enrolled. With regard to the latter, this also includes patients who have already undergone surgery in the past and whose paraffin-coated tissues are preserved. * Healthy subjects over eighty years of age with a clinical history free from a diagnosis of tumor or neoplastic pathology treated during their life. The choice of these control subjects not matched by age to the patients is based on the rationale that they can be considered de facto "protected" from the tumor pathology. Consequently, they represent the true negative control of the study.
Who may be able to join
- Histological diagnosis of primary HCC and other oncological pathology (Pascale Institute) or diagnosis of oncological pathology (without any exclusions) from an accredited medical-clinical facility (Fortore Mountain Community).
- Age ≥18 years
- Ability to give signed informed consent that includes compliance with the requirements and constraints listed in the informed consent form (ICF) and in this protocol.
- In the case of paraffin-embedded samples obtained from the UOC of Pathological Anatomy and/or the Institute's Biological Bank, informed consent cannot be acquired, in accordance with the Provision of the Privacy Authority containing the requirements relating to the processing of special categories of data, pursuant to art. 21, paragraph 1 of Legislative Decree 10 August 2018, no. 101, published in the Official Journal - general series - no. 176 of 29/07/2019, point 5 "Provisions relating to the processing of personal data carried out for scientific research purposes (gen. aut. n. 9/2016)" HEALTHY SUBJECTS
- clinical history free from diagnosis of tumor or neoplastic pathology treated during life
- Age ≥80 years
- Ability to give signed informed consent that includes compliance with the requirements and constraints listed in the informed consent form (ICF) and in this protocol
Who cannot join
- Current pathologies requiring antibiotic therapy
- Diagnosis of pre-tumor pathology (in healthy subjects)
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
Istituto Nazionale Tumori di Napoli - IRCCS - Fondazione G. Pascale
Naples, 80131
Luigi Buonaguro, DR, 08117770587, l.buonaguro@istitutotumori.na.it
About this study
Official title: Tumor Antigen Discovery for Innovative Cancer Immunotherapies in HCC: from Benchside to Bedside (HepAnt) - Study of the Role of the Metagenome in Head and Neck Tumors Using Omics Techniques - HeNomics
Tumor Antigen Discovery for Innovative Cancer Immunotherapies in HCC: From Benchside to Bedside (HepAnt) - Study of the Role of the Metagenome in Head and Neck Tumors Using Omics Techniques (HeNomics).
Read the detailed description
The aim of this study is to:
- Analyze and compare the microbiota and the intestinal, salivary and intratumoral microbiome in patients with HCC, patients diagnosed with oncological pathology and in healthy subjects. The analysis of the mycobiota will be carried out by analyzing bacterial culture media, that of the microbiome by genomic analysis. The evaluation will be made by taking into account multiple taxonomic levels: phylum, class, order, family, genus and species.
- Identify tumor antigens (TuAs) with sequence homology with peptides derived from the microbiota/microbiome by bioinformatic analysis. The sequences of tumor antigens known from the literature (https://caped.icp.ucl.ac.be/Peptide/list) will be aligned with sequences derived from bacteria identified in the microbiota/microbiome of patients and healthy subjects.
- Conditions
- Hepatocellular Carcinoma
- Medical subject headings
- Carcinoma, Hepatocellular
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification and classification of the numerical variation
Identification and classification of the numerical variation (appearance or disappearance) of bacterial species and/or their representativeness (percentage of the total) in the intestinal, salivary and intratumoral microbiota/microbiome of the two groups of enrolled subjects.
Measured: approximately 16 months
Identification and classification of the different number and identity of antigens
Identification and classification of the different number and identity of antigens predicted by the bacterial species present in the intestinal, salivary and intratumoral microbiota/microbiome of the two groups of enrolled subjects.
Measured: approximately 16 months
Identification and classification of the number and identity of TuAs
Identification and classification of the number and identity of TuAs that share sequence homology with peptides derived from bacteria that are components of the intestinal, salivary and intratumoral microbiota/microbiome of the two groups of enrolled subjects.
Measured: approximately 16 months
Secondary outcomes (2)
Identification of the percentage of memory CD8+ T lymphocytes
- Identification of the percentage of memory CD8+ T lymphocytes in the two groups of enrolled subjects showing cross-reactivity against TuAs and epitopes derived from bacteria that are components of the intestinal, salivary and intratumoral microbiota/microbiome.
Measured: approximately 16 months
Identification and classification of numerical variation
Identification and classification of the numerical variation (appearance or disappearance) and/or their representativeness (percentage of the total) of the TCR sequences of CD8+ T cells in the two groups of enrolled subjects cross-reactive with TuAs and epitopes derived from bacteria that are components of the intestinal, salivary and intratumoral microbiota/microbiome.
Measured: approximately 16 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2025
- Study start2 Jan 2023
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies 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
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute, Naples
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luigi Buonaguro, Principal investigator, IRCCS I.N.T. "G. Pascale"
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06905262
- Sponsor's protocol ID
- 57/22 oss (HepAnt)
- Status last verified
- Mar 2025
- First submitted
- 25 Mar 2025
- Last updated
- 1 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tumor Antigen Discovery for Innovative Cancer Immunotherapies in HCC: from Benchside to Bedside (HepAnt) - Study of the Role of the Metagenome in Head and Neck Tumors Using Omics Techniques - HeNomics
- ClinicalTrials.gov ID
- NCT06905262
- Acronym / sponsor ID
- 57/22 oss (HepAnt)
- Conditions
- Hepatocellular Carcinoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- National Cancer Institute, NaplesUniversity, hospital or other
- Study start
- 2 Jan 2023 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 1 Apr 2025 (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.
Tumor Antigen Discovery for Innovative Cancer Immunotherapies in HCC: From Benchside to Bedside (HepAnt) - Study of the Role of the Metagenome in Head and Neck Tumors Using Omics Techniques (HeNomics).
Detailed description
The aim of this study is to:
- Analyze and compare the microbiota and the intestinal, salivary and intratumoral microbiome in patients with HCC, patients diagnosed with oncological pathology and in healthy subjects. The analysis of the mycobiota will be carried out by analyzing bacterial culture media, that of the microbiome by genomic analysis. The evaluation will be made by taking into account multiple taxonomic levels: phylum, class, order, family, genus and species.
- Identify tumor antigens (TuAs) with sequence homology with peptides derived from the microbiota/microbiome by bioinformatic analysis. The sequences of tumor antigens known from the literature (https://caped.icp.ucl.ac.be/Peptide/list) will be aligned with sequences derived from bacteria identified in the microbiota/microbiome of patients and healthy subjects.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- * Patients with primary hepatocellular carcinoma attending the Institute for medical/surgical treatment (surgery, locoregional treatments, systemic pharmacological treatments). In addition, patients with a diagnosis of oncological pathology attending the Institute will be enrolled. With regard to the latter, this also includes patients who have already undergone surgery in the past and whose paraffin-coated tissues are preserved. * Healthy subjects over eighty years of age with a clinical history free from a diagnosis of tumor or neoplastic pathology treated during their life. The choice of these control subjects not matched by age to the patients is based on the rationale that they can be considered de facto "protected" from the tumor pathology. Consequently, they represent the true negative control of the study.
Key inclusion criteria (7 listed)
- Histological diagnosis of primary HCC and other oncological pathology (Pascale Institute) or diagnosis of oncological pathology (without any exclusions) from an accredited medical-clinical facility (Fortore Mountain Community).
- Age ≥18 years
- Ability to give signed informed consent that includes compliance with the requirements and constraints listed in the informed consent form (ICF) and in this protocol.
- In the case of paraffin-embedded samples obtained from the UOC of Pathological Anatomy and/or the Institute's Biological Bank, informed consent cannot be acquired, in accordance with the Provision of the Privacy Authority containing the requirements relating to the processing of special categories of data, pursuant to art. 21, paragraph 1 of Legislative Decree 10 August 2018, no. 101, published in the Official Journal - general series - no. 176 of 29/07/2019, point 5 "Provisions relating to the processing of personal data carried out for scientific research purposes (gen. aut. n. 9/2016)" HEALTHY SUBJECTS
- clinical history free from diagnosis of tumor or neoplastic pathology treated during life
Key exclusion criteria (2 listed)
- Current pathologies requiring antibiotic therapy
- Diagnosis of pre-tumor pathology (in healthy subjects)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Identification and classification of the numerical variation
Time frame: approximately 16 months
Identification and classification of the numerical variation (appearance or disappearance) of bacterial species and/or their representativeness (percentage of the total) in the intestinal, salivary and intratumoral microbiota/microbiome of the two groups of enrolled subjects.
Identification and classification of the different number and identity of antigens
Time frame: approximately 16 months
Identification and classification of the different number and identity of antigens predicted by the bacterial species present in the intestinal, salivary and intratumoral microbiota/microbiome of the two groups of enrolled subjects.
Identification and classification of the number and identity of TuAs
Time frame: approximately 16 months
Identification and classification of the number and identity of TuAs that share sequence homology with peptides derived from bacteria that are components of the intestinal, salivary and intratumoral microbiota/microbiome of the two groups of enrolled subjects.
2 secondary outcomes
Identification of the percentage of memory CD8+ T lymphocytes
Time frame: approximately 16 months
Identification and classification of numerical variation
Time frame: approximately 16 months
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 1 Apr 2025.
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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.
Luigi Buonaguro principal investigator
IRCCS I.N.T. "G. Pascale"
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 Hepatocellular Carcinoma, run by National Cancer Institute, Naples 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?
The sponsor lists 7 inclusion and 2 exclusion criteria. 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 1 Apr 2025. 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 Luigi Buonaguro, DR (08117770587, l.buonaguro@istitutotumori.na.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification and classification of the numerical variation (time frame: approximately 16 months). The study lists 3 primary outcomes in all. 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 1 Apr 2025.