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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Squamous Cell Carcinoma of the Head and Neck
- Sponsor
- National Cancer Institute, Naples
- Enrollment
- 170
- Locations
- 4
- Primary Endpoint
- Primary Endpoint
- Status
- Recruiting
- Last Updated
- 9 months ago
Overview
Brief Summary
This is a multicentric, retrospective, and prospective biomarker study.
Detailed Description
This is a multicentric, retrospective, and prospective biomarker study, involving a total of 170 patients with SCC (Squamous Cell Carcinoma) of the mucosa of the anogenital tract and head-neck region, recruited from INT-NA (n=50), UPO (n=40), AOUP (n=40), and ITB (n=40). Specifically, 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.
Investigators
Eligibility 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:
- •Metastatic neoplasia
- •Treatment for other oncological pathologies
- •Congenital or acquired immunosuppression (HIV, organ transplant, pharmacological)
Outcomes
Primary Outcomes
Primary Endpoint
Time Frame: 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).
Secondary Outcomes
- Secondary Endpoint(30 months)