Clinical trial NCT06236464: Identification of the Pathogenetic Mechanisms Underlying 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Squamous Cell Carcinoma of the Head and Neck
Squamous Cell Carcinoma of the Anus
Lead sponsor: National Cancer Institute, Naples
Sponsor class: OTHER
First posted: 2024-02-01
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population consists of patients with a histological diagnosis of squamous cell carcinoma (SCC) of the anus, cervix, vulva, oral cavity, and oropharynx. At least 170 cases of anal SCC (n=30), cervical SCC (n=30), vulvar SCC (n=30), oral cavity SCC (n=40), and oropharyngeal SCC (n=40) will be prospectively enrolled and retrospectively analyzed.

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.

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:

1. Metastatic neoplasia
2. Treatment for other oncological pathologies
3. Congenital or acquired immunosuppression (HIV, organ transplant, pharmacological)

Primary outcomes:
measure: Primary Endpoint
timeFrame: 30 months
Secondary outcomes:
measure: Secondary Endpoint
timeFrame: 30 months
Other outcomes:
Locations:
city: Bari
country: Italy
facility: Istituto Tumori IRCCS Giovanni Paolo II di Bari
city: Napoli
country: Italy
facility: Istituto Nazionale Tumori | "Fondazione Pascale"
city: Novara
country: Italy
facility: Università del Piemonte orientale
city: Pisa
country: Italy
facility: Azienda Ospedaliera Universitaria Pisana
Study officials:
affiliation: IRCCS I.N.T. "G. Pascale"
name: Maria Lina Tornesello, M.D.
role: PRINCIPAL_INVESTIGATOR
References: