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

NCT06905262 | Recruiting

• 1 other identifier: 57/22 oss (HepAnt)
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  approximately 16 months

Secondary Outcomes (2)

• Identification of the percentage of memory CD8+ T lymphocytes

  approximately 16 months

• Identification and classification of numerical variation

  approximately 16 months

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• National Cancer Institute, Naples: lead

Study Sites (1)

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

Napoli, 80131, Italy

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Luigi Buonaguro

  IRCCS I.N.T. "G. Pascale"

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Luigi Buonaguro, DR

CONTACT

08117770587; l.buonaguro@istitutotumori.na.it

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2025
• First Posted: April 1, 2025
• Study Start: January 2, 2023
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: April 1, 2025

Record last verified: 2025-03

Locations

IT (1)