Actively Recruiting
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
Led by National Cancer Institute, Naples · Updated on 2025-07-29
170
Participants Needed
4
Research Sites
14 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the underlying mechanisms of squamous cell carcinomas (SCC) affecting the mucous membranes of the anogenital tract and head-neck region. This multicenter study combines both retrospective and prospective approaches, including 170 patients from several institutions. The goal is to analyze molecular and viral biomarkers to better understand these cancers and to develop shared therapeutic strategies. The study involves collecting and examining tissue samples from past and current patients. Fibroblastic tumor-associated cells (CAFs) will be isolated from new samples and grown alongside immortalized cell lines to create 3D organoids. These organoids will be used to test responses to telomerase and SIRT1 deacetylase inhibitors in laboratory and preclinical experiments. Participants will provide samples that undergo multiparameter analysis for biomarkers. Researchers will study these markers over a 30-month period to evaluate primary and secondary outcomes. There is no intervention directly involving participants beyond sample collection and analysis. The study focuses on laboratory and preclinical assessments, without altering patient treatment, and will continue monitoring results through this timeframe.
CONDITIONS
Brief Title
Identification of the Pathogenetic Mechanisms Underlying Squamous Cell Carcinomas
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 years or older
- Candidates for surgical treatment for squamous cell carcinoma of the anus, uterine cervix, vulva, or head-neck region
- Patients with microinvasive or invasive squamous cell carcinomas
- Patients capable of understanding and willing to sign the informed consent form
- Prospective patients must provide written informed consent before any procedures
You will not qualify if you...
- Patients with metastatic cancer
- Patients receiving treatment for other cancers
- Patients with congenital or acquired immunosuppression, including HIV, organ transplant, or pharmacological causes
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 30 months
Participants provide retrospective and prospective tissue samples which are analyzed for molecular and viral biomarkers. Fibroblastic tumor-associated cells are isolated from prospective samples to produce 3D organoids for experimental assessments.
1 to 2 visits depending on sample collection and analysis
Trial Site Locations
Total: 4 locations
1
Istituto Tumori IRCCS Giovanni Paolo II di Bari
Bari, Bari, Italy, 70124
Actively Recruiting
2
Istituto Nazionale Tumori | "Fondazione Pascale"
Naples, Napoli, Italy, 80131
Actively Recruiting
3
Università del Piemonte orientale
Novara, Novara, Italy, 28100
Actively Recruiting
4
Azienda Ospedaliera Universitaria Pisana
Pisa, Pisa, Italy, 56126
Actively Recruiting
Research Team
M
Maria Lina Tornesello, M.D.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here