Understanding the mechanisms behind squamous cell carcinomas
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
Run by National Cancer Institute, Naples · NCT06236464 · Data updated 2026-11-12
This study is trying to learn more about squamous cell carcinoma by looking at samples from patients to see how certain markers and cells affect the disease and its treatment.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 170 (estimated) |
| Sponsor | National Cancer Institute, Naples Academic / other |
| Locations | 4 sites (Bari, Bari and 3 other locations) |
| Status | Recruiting |
| Started | September 25, 2023 |
| Main results expected | November 19, 2025 |
| Study ends | March 2026 |
| Registry record updated | July 29, 2025 |
| Trial ID | NCT06236464 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older with squamous cell carcinoma of the anus, uterine cervix, vulva, or head-neck region who are eligible for surgical treatment.
✕Probably not a fit
Patients with metastatic neoplasia, other oncological treatments, or immunosuppression may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This multicentric observational study involves 170 patients with squamous cell carcinoma (SCC) of the head and neck and anogenital tract. It aims to collect and analyze both retrospective and prospective samples to investigate molecular and viral biomarkers associated with SCC. Additionally, fibroblastic tumor-associated cells will be isolated from prospective samples to create 3D organoids for experimental assessment of responses to specific inhibitors. The study seeks to enhance understanding of SCC pathogenesis and treatment responses.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for patients with squamous cell carcinomas.
How similar studies have gone: Other studies have shown promise in understanding SCC through biomarker analysis, but this specific approach is novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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)
Where it's running
-
Istituto Tumori IRCCS Giovanni Paolo II di Bari
Bari, Bari, Italy Recruiting -
Istituto Nazionale Tumori | "Fondazione Pascale"
Naples, Napoli, Italy Recruiting -
Università del Piemonte orientale
Novara, Novara, Italy Recruiting -
Azienda Ospedaliera Universitaria Pisana
Pisa, Pisa, Italy Recruiting
Study contacts
- Principal investigator: Maria Lina Tornesello, M.D. — IRCCS I.N.T. "G. Pascale"
- Study coordinator: Maria Lina Tornesello, M.D.
- Email: m.tornesello@istitutotumori.na.it
- Phone: 08117770588
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.