Identification of the Pathogenetic Mechanisms Underlying Squamous Cell Carcinomas

ConditionsSquamous Cell Carcinoma of the Head and Neck Squamous Cell Carcinoma of the Anus

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorNational Cancer Institute, Naples

About this trial

This is a multicentric, retrospective, and prospective biomarker study.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

Metastatic neoplasia

Treatment for other oncological pathologies

Congenital or acquired immunosuppression (HIV, organ transplant, pharmacological)

Trial 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.

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

Multiparameter analysis of each sample
Other intervention
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.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

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).

Time frame

30 months

Secondary outcomes

Secondary Endpoint

Inhibition of growth in organoids obtained from tumor cells mutated in the TERT promoter or expressing viral oncogenes and SIRT1.

Time frame

30 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

National Cancer Institute, Naples

Lead sponsor

Source ClinicalTrials.gov

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