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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-100
SponsorNational Cancer Institute, Naples

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Current pathologies requiring antibiotic therapy

Diagnosis of pre-tumor pathology (in healthy subjects)

Trial 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.

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

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.

Time frame
approximately 16 months
2

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.

Time frame
approximately 16 months
3

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.

Time frame
approximately 16 months

Secondary outcomes

1

Identification of the percentage of memory CD8+ T lymphocytes

\- 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.

Time frame
approximately 16 months
2

Identification and classification of numerical variation

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.

Time frame
approximately 16 months

Other outcomes

Sponsors and contacts

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