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

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

Study Overview

• Status: Recruiting
• Conditions: Squamous Cell Carcinoma of the Head and Neck; Squamous Cell Carcinoma of the Anus
• Intervention / Treatment: Other: Multiparameter analysis of each sample

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 Type: Observational
• Enrollment (Estimated): 170

Contacts and Locations

• Study Contact: Name: Maria Lina Tornesello, M.D.; Phone Number: 08117770588; Email: m.tornesello@istitutotumori.na.it

Study Locations

• Italy
  • Bari, Italy, 70124
    • Recruiting
    • Istituto Tumori IRCCS Giovanni Paolo II di Bari
    • Contact: Oronzo Brunetti, M.D; Email: dr.oronzo.brunetti1983@gmail.com
  • Napoli, Italy, 80131
    • Recruiting
    • Istituto Nazionale Tumori | "Fondazione Pascale"
    • Contact: Maria Lina Tornesello, M.D.; Phone Number: 08117770588; Email: m.tornesello@istitutotumori.na.it
  • Novara, Italy, 28100
    • Recruiting
    • Universita del piemonte Orientale
    • Contact: Marisa Gariglio, M.D.; Email: marisa.gariglio@med.uniupo.it
  • Pisa, Italy, 56126
    • Recruiting
    • Azienda Ospedaliera Universitaria Pisana
    • Contact: Mauro Pistello, M.D.; Phone Number: 050 221 3781; Email: mauro.pistello@unipi.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

The study population consists of patients with a histological diagnosis of squamous cell carcinoma (SCC) of the anus, cervix, vulva, oral cavity, and oropharynx. At least 170 cases of anal SCC (n=30), cervical SCC (n=30), vulvar SCC (n=30), oral cavity SCC (n=40), and oropharyngeal SCC (n=40) will be prospectively enrolled and retrospectively analyzed.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: National Cancer Institute, Naples
• Investigators: Principal Investigator: Maria Lina Tornesello, M.D., IRCCS I.N.T. "G. Pascale"

Study record dates

Study Major Dates

• Study Start (Actual): September 25, 2023
• Primary Completion (Estimated): November 19, 2025
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: January 24, 2024
• First Submitted That Met QC Criteria: January 24, 2024
• First Posted (Actual): February 1, 2024

Study Record Updates

• Last Update Posted (Actual): July 29, 2025
• Last Update Submitted That Met QC Criteria: July 24, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Neoplasms by Histologic Type; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Rectal Diseases; Head and Neck Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Squamous Cell; Anus Diseases; Rectal Neoplasms; Squamous Cell Carcinoma of Head and Neck; Carcinoma; Carcinoma, Squamous Cell; Anus Neoplasms
• Other Study ID Numbers: PNRR-MAD-2022-12376570; 9/23 oss (Other Identifier: IRCCS I.N.T. "G. Pascale")

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No