Understanding the mechanisms behind 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 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 |
|---|---|
| Enrollment | 170 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | National Cancer Institute, Naples Academic / other |
| Locations | 4 sites (Bari, Bari and 3 other locations) |
| Trial ID | NCT06236464 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with metastatic neoplasia, other oncological treatments, or immunosuppression may not benefit from this study.
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 performed: Other studies have shown promise in understanding SCC through biomarker analysis, but this specific approach is novel.
Eligibility criteria
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 this trial is running
Bari, Bari and 3 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.