Identification of the Pathogenetic Mechanisms Underlying Squamous Cell Carcinomas

NCT06236464 | Recruiting

• 2 other identifiers: PNRR-MAD-2022-123765709/23 oss
• Study Type: observational
• Target: 170
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Secondary Endpoint

  30 months

Interventions

Multiparameter analysis of each sample OTHER

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 Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Metastatic neoplasia
• Treatment for other oncological pathologies
• Congenital or acquired immunosuppression (HIV, organ transplant, pharmacological)

Sponsors & Collaborators

• National Cancer Institute, Naples: lead

Study Sites (4)

Istituto Tumori IRCCS Giovanni Paolo II di Bari

Bari, Bari, 70124, Italy

RECRUITING

Istituto Nazionale Tumori | "Fondazione Pascale"

Napoli, Napoli, 80131, Italy

RECRUITING

Università del Piemonte orientale

Novara, Novara, 28100, Italy

RECRUITING

Azienda Ospedaliera Universitaria Pisana

Pisa, Pisa, 56126, Italy

RECRUITING

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Anus Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Rectal Neoplasms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Anus Diseases; Rectal Diseases

Study Officials

• Maria Lina Tornesello, M.D.

  IRCCS I.N.T. "G. Pascale"

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria Lina Tornesello, M.D.

CONTACT

08117770588; m.tornesello@istitutotumori.na.it

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2024
• First Posted: February 1, 2024
• Study Start: September 25, 2023
• Primary Completion: November 19, 2025
• Study Completion: March 1, 2026
• Last Updated: July 29, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (4)