NCT06236464

Identification of the Pathogenetic Mechanisms Underlying Squamous Cell Carcinomas

Identification of the Pathogenetic Mechanisms Underlying Squamous Cell Carcinomas of the Anogenital Tract and of the Head-neck Region for the Development of Shared Therapeutic Strategies

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 170 (estimated)
• Sponsor: National Cancer Institute, Naples · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
OTHER	Multiparameter analysis of each sample	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.

Timeline

• Start date: 2023-09-25
• Primary completion: 2025-11-19
• Completion: 2026-03-01
• First posted: 2024-02-01
• Last updated: 2025-07-29

Locations

4 sites across 1 country: Italy