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

National Cancer Institute, Naples

Status: Enrolling

Conditions: Hepatocellular Carcinoma

Study type: Observational

Funder types: Other

Identifiers

NCT06905262

57/22 oss (HepAnt)

Details and patient eligibility

About

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).

Full 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.

Enrollment: 70 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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)