Identification of the Pathogenetic Mechanisms Underlying Squamous Cell Carcinomas

Recruiting

• Conditions: Squamous Cell Carcinoma of the Head and Neck; Squamous Cell Carcinoma of the Anus

• Registration Number: NCT06236464
• Lead Sponsor: National Cancer Institute, Naples

Brief Summary

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

Detailed Description

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 Timeline

• Study Start: 2023-09-25
• Status Verified: 2024-01
• Study First Submitted: 2024-01-24
• Study First Submitted QC: 2024-01-24
• Last Update Submitted: 2024-01-24
• Study First Posted: 2024-02-01
• Last Update Posted: 2024-02-01
• Primary Completion: 2025-11-19
• Study Completion: 2026-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 170

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary Endpoint	30 months	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).

Secondary Outcome Measures

Name	Time	Method
Secondary Endpoint	30 months	Inhibition of growth in organoids obtained from tumor cells mutated in the TERT promoter or expressing viral oncogenes and SIRT1.

Trial Locations

Locations (4)

Istituto Tumori IRCCS Giovanni Paolo II di Bari; 🇮🇹 Bari, Italy

Istituto Nazionale Tumori | "Fondazione Pascale"; 🇮🇹 Napoli, Italy

Università del Piemonte orientale; 🇮🇹 Novara, Italy

Azienda Ospedaliera Universitaria Pisana; 🇮🇹 Pisa, Italy