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Recruiting Observational

Identification of the Pathogenetic Mechanisms Underlying Squamous Cell Carcinomas

NCT06236464 · tracked via the Priya Life Science Italy tracker
Phase
Observational
Started
2023-09-25
Last updated
2025-07-29

Condition(s) studied

Squamous Cell Carcinoma of the Head and NeckSquamous Cell Carcinoma of the Anus

Investigational drug(s) / intervention(s)

Multiparameter analysis of each sample

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.

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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)

Primary outcome measure(s)

  • 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).

Trial sites (4)

FacilityCityRegionStatus
Istituto Tumori IRCCS Giovanni Paolo II di Bari Bari Bari Recruiting
Istituto Nazionale Tumori | "Fondazione Pascale" Naples Napoli Recruiting
Università del Piemonte orientale Novara Novara Recruiting
Azienda Ospedaliera Universitaria Pisana Pisa Pisa Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06236464 on ClinicalTrials.gov ↗ ← All trials in Italy