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).
Eligibility
Sex
ALL
Min age
18 Years
Max age
100 Years
Healthy volunteers
No
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)
Primary outcome measure(s)
Identification and classification of the numerical variation — 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 — 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 — 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.
Trial sites (1)
Facility
City
Region
Status
Istituto Nazionale Tumori di Napoli - IRCCS - Fondazione G. Pascale
Naples
Italy
Recruiting
More National Cancer Institute, Naples trials in Italy
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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