Identification of the Pathogenetic Mechanisms Underlying Squamous Cell Carcinomas
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Multiparameter analysis of each sample.
- Who it may be relevant to
- Registry conditions: Squamous Cell Carcinoma of the Head and Neck, Squamous Cell Carcinoma of the Anus. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- Other Multiparameter analysis of each sample
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 mod
Primary outcome measures
- Primary Endpoint [Time frame: 30 months]
Secondary outcome measures (1)
- Secondary Endpoint [Time frame: 30 months]
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
Italy · 4 centers
- Istituto Tumori IRCCS Giovanni Paolo II di Bari — Bari
- Istituto Nazionale Tumori | "Fondazione Pascale" — Naples
- Università del Piemonte orientale — Novara
- Azienda Ospedaliera Universitaria Pisana — Pisa
Identifiers
NCT: NCT06236464 · PNRR-MAD-2022-12376570 · 9/23 oss