Identification of the Pathogenetic Mechanisms Underlying Squamous Cell Carcinomas

National Cancer Institute, Naples170 enrolled

Overview

This is a multicentric, retrospective, and prospective biomarker study.

This is a multicentric, retrospective, and prospective biomarker study, involving a total of 170 patients with SCC (Squamous Cell Carcinoma) of the mucosa of the anogenital tract and head-neck region, recruited from INT-NA (n=50), UPO (n=40), AOUP (n=40), and ITB (n=40). Specifically, retrospective and prospective samples will be collected and analyzed for the study of molecular and viral biomarkers. Simultaneously, fibroblastic tumor-associated cells (CAFs) will be isolated from prospective samples. Through co-cultivation with immortalized cell lines derived from anogenital and head-neck SCCs, these CAFs will enable the production of 3D organoids for use in experiments assessing the response to telomerase and deacetylase SIRT1 inhibitors, both in vitro and in preclinical models.

Study Type

OBSERVATIONAL

Enrollment

170

Conditions

Squamous Cell Carcinoma of the Head and Neck Squamous Cell Carcinoma of the Anus

Interventions

Multiparameter analysis of each sampleOTHER

Retrospective and prospective samples will be collected and analyzed for the study of molecular and viral biomarkers. Simultaneously, fibroblastic tumor-associated cells (CAFs) will be isolated from prospective samples. Through co-cultivation with immortalized cell lines derived from anogenital and head-neck SCCs, these CAFs will enable the production of 3D organoids for use in experiments assessing the response to telomerase and deacetylase SIRT1 inhibitors, both in vitro and in preclinical models.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: Patients aged ≥ 18 years, candidates for surgical treatment for squamous cell carcinoma of the anus, uterine cervix, vulva, and head-neck region (including microinvasive and invasive carcinomas) who are capable of understanding and willing to sign the informed consent form. Prospective patients must provide written informed consent before any procedures. Exclusion Criteria: Patients presenting any of the following criteria are not eligible for inclusion in this study. Exclusion criteria include: 1. Metastatic neoplasia 2. Treatment for other oncological pathologies 3. Congenital or acquired immunosuppression (HIV, organ transplant, pharmacological)

Locations (4)

Istituto Tumori IRCCS Giovanni Paolo II di Bari

Bari, Bari, Italy

RECRUITING

Istituto Nazionale Tumori | "Fondazione Pascale"

Naples, Napoli, Italy

RECRUITING

Università del Piemonte orientale

Novara, Novara, Italy

RECRUITING

Outcomes

Primary Outcomes

Primary Endpoint

Identify shared molecular profiles in squamous cell carcinomas (SCC) of the mucosa of the anogenital tract and head-neck region, dependent on the presence of somatic mutations (e.g., TERT promoter mutations and viral HPV sequences).

Time frame: 30 months

Secondary Outcomes

Secondary Endpoint

Inhibition of growth in organoids obtained from tumor cells mutated in the TERT promoter or expressing viral oncogenes and SIRT1.

Time frame: 30 months

Central Contacts

Maria Lina Tornesello, M.D.

CONTACT

08117770588 m.tornesello@istitutotumori.na.it

Data from ClinicalTrials.gov

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