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NCT06236464 Clinical Trial

Identification of the Pathogenetic Mechanisms Underlying Squamous Cell Carcinomas

Squamous Cell Carcinoma of the Head and Neck Clinical Trial

Official title:
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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06236464
Other study ID # PNRR-MAD-2022-12376570
Secondary ID 9/23 oss
Status Recruiting
Phase
First received
Last updated
Start date September 25, 2023
Est. completion date March 2026

Study information
Verified date January 2024
Source National Cancer Institute, Naples
Contact Maria Lina Tornesello, M.D.
Phone 08117770588
Email m.tornesello@istitutotumori.na.it
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 170
Est. completion date March 2026
Est. primary completion date November 19, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
Italy 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

Sponsors (1)
Lead Sponsor Collaborator
National Cancer Institute, Naples

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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). 30 months
Secondary Secondary Endpoint Inhibition of growth in organoids obtained from tumor cells mutated in the TERT promoter or expressing viral oncogenes and SIRT1. 30 months
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