Discovering tumor antigens for innovative cancer treatments in liver cancer

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

This study is trying to find new cancer treatments for liver cancer by looking at the gut bacteria in patients and seeing how it compares to healthy people and those with other cancers.

Quick facts

• Study type: Observational
• Enrollment: 70 (estimated)
• Ages: 18 Years to 100 Years
• Sex: All
• Sponsor: National Cancer Institute, Naples (Academic / other)
• Locations: 1 site (Naples)
• Trial ID: NCT06905262 on ClinicalTrials.gov

What this trial studies

This study aims to analyze the microbiota and microbiome in patients with hepatocellular carcinoma (HCC) and compare it with healthy subjects and those with other oncological pathologies. It utilizes omics techniques to evaluate the intestinal, salivary, and intratumoral microbiomes, focusing on multiple taxonomic levels. Additionally, the study seeks to identify tumor antigens that share sequence homology with peptides derived from the microbiota through bioinformatic analysis.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with a histological diagnosis of primary hepatocellular carcinoma or other oncological conditions.

Not a fit: Patients without a diagnosis of hepatocellular carcinoma or other oncological pathologies may not benefit from this study.

Why it matters

Potential benefit: If successful, this research could lead to the development of innovative immunotherapies for patients with liver cancer.

How similar studies have performed: While this approach is innovative, similar studies exploring the relationship between microbiomes and cancer have shown promising results, indicating potential for success.

Eligibility criteria

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)

Where this trial is running

Naples

• Istituto Nazionale Tumori di Napoli - IRCCS - Fondazione G. Pascale — Naples, Italy (Recruiting)

Study contacts

• Principal investigator: Luigi Buonaguro — IRCCS I.N.T. "G. Pascale"
• Study coordinator: Luigi Buonaguro, DR

Conditions Hepatocellular Carcinoma