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Trial Title:
Identification of the Pathogenetic Mechanisms Underlying Squamous Cell Carcinomas
NCT ID:
NCT06236464
Condition:
Squamous Cell Carcinoma of the Head and Neck
Squamous Cell Carcinoma of the Anus
Conditions: Official terms:
Carcinoma
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Anus Neoplasms
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
Multiparameter analysis of each sample
Description:
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.
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.
Criteria for eligibility:
Study pop:
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.
Sampling method:
Probability Sample
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)
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Istituto Tumori IRCCS Giovanni Paolo II di Bari
Address:
City:
Bari
Zip:
70124
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Oronzo Brunetti, M.D
Email:
dr.oronzo.brunetti1983@gmail.com
Facility:
Name:
Istituto Nazionale Tumori | "Fondazione Pascale"
Address:
City:
Napoli
Zip:
80131
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Maria Lina Tornesello, M.D.
Phone:
08117770588
Email:
m.tornesello@istitutotumori.na.it
Facility:
Name:
Università del Piemonte orientale
Address:
City:
Novara
Zip:
28100
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Marisa Gariglio, M.D.
Email:
marisa.gariglio@med.uniupo.it
Facility:
Name:
Azienda Ospedaliera Universitaria Pisana
Address:
City:
Pisa
Zip:
56126
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Mauro Pistello, M.D.
Phone:
050 221 3781
Email:
mauro.pistello@unipi.it
Start date:
September 25, 2023
Completion date:
March 2026
Lead sponsor:
Agency:
National Cancer Institute, Naples
Agency class:
Other
Source:
National Cancer Institute, Naples
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06236464
