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| ID | Type | Description | Link |
|---|---|---|---|
| 9/23 oss | Other Identifier | IRCCS I.N.T. "G. Pascale" |
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This is a multicentric, retrospective, and prospective biomarker study.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multiparameter analysis of each sample | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Primary Endpoint | 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). | 30 months |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary Endpoint | Inhibition of growth in organoids obtained from tumor cells mutated in the TERT promoter or expressing viral oncogenes and SIRT1. | 30 months |
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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:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maria Lina Tornesello, M.D. | Contact | 08117770588 | m.tornesello@istitutotumori.na.it |
| Name | Affiliation | Role |
|---|---|---|
| Maria Lina Tornesello, M.D. | IRCCS I.N.T. "G. Pascale" | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istituto Tumori IRCCS Giovanni Paolo II di Bari | Recruiting | Bari | Bari | 70124 | Italy |
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| ID | Term |
|---|---|
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| D001005 | Anus Neoplasms |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| Istituto Nazionale Tumori | "Fondazione Pascale" | Recruiting | Naples | Napoli | 80131 | Italy |
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| Università del Piemonte orientale | Recruiting | Novara | Novara | 28100 | Italy |
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| Azienda Ospedaliera Universitaria Pisana | Recruiting | Pisa | Pisa | 56126 | Italy |
|
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D012004 | Rectal Neoplasms |
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D001004 | Anus Diseases |
| D012002 | Rectal Diseases |