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NCT Number: NCT06905262

Tumor Antigen Discovery for Innovative Cancer Immunotherapies in HCC: from Benchside to Bedside (HepAnt)

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).

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Istituto Nazionale Tumori di Napoli - IRCCS - Fondazione G. Pascale

Naples, 80131, Italy

Location status: Recruiting

Location contact

Luigi Buonaguro, DR

CONTACT

[email protected]

08117770587

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Current pathologies requiring antibiotic therapy
  • Diagnosis of pre-tumor pathology (in healthy subjects)

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. Identification of the percentage of memory CD8+ T lymphocytes

    Time frame: approximately 16 months

    • 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.
  2. Identification and classification of numerical variation

    Time frame: approximately 16 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Luigi Buonaguro, DR

CONTACT

[email protected]

08117770587

Sponsors and collaborators

Lead sponsor

National Cancer Institute, Naples

Other

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Apr 1, 2025
Registry last updated
Apr 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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