Clinical trial NCT06821243: Patients with Human Papillomavirus-associated Head and Neck Cancer for the Discovery of Predictive Biomarkers to Guide Clinical Intervention
Official title: Multidimensional Assessment of Virus-associated Head and Neck Cancer Patients for the Discovery of Predictive Biomarkers to Guide Clinical Intervention
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Squamous Cell Carcinoma of Oropharynx
Keywords: carcinoma of the oropharynx
squamous cell carcinoma of the oropharynx
head and neck
Lead sponsor: Regina Elena Cancer Institute
Sponsor class: OTHER
Collaborators: name: Università della Campania Luigi Vanvitelli
name: Università di Napoli Federico II
name: I.R.C.C.S. Fondazione Santa Lucia, Italy
First posted: 2025-02-11
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients affected by oropharynx squamous cell carcinoma (OPSCC) in head and neck district

Brief summary: Prospective pilot study, non-interventional, of a biological/radiological nature, which involves the collection of tissue samples, and blood from patients suffering from squamous cell carcinoma of the oropharynx OPSCC for detection of HPV-DNA/RNA and immuno-phenotypic analysis of T cells, study of extracellular vesicles, and dosages of cytokines and chemokines involved in the immune response

Detailed description: The study involves the collection of tissue samples, and blood from patients suffering from squamous cell carcinoma of the oropharynx OPSCC for detection of HPV-DNA/RNA and immuno-phenotypic analysis of T cells, study of extracellular vesicles, and dosages of cytokines and chemokines involved in the immune response. Radiological images will be collected during diagnosis, treatment and the care path, with exploratory and research purposes only, without the results modifying the care path and the diagnostic-therapeutic process of the patients participants. Molecular analyzes and/or material extraction will not be conducted genomic/protein of any kind. The objective is to observe the kinetics of the levels of HPV-DNA circulating in the blood patients with oropharynx cancers HPV related to the diagnosis and during the care pathway patient. The blood of HPV-negative patients will be tested to confirm that there are no copies of circulating HPV-DNA. The aim is to collect the information necessary to improve understanding and managing HPV-associated OPSCC.

Eligibility criteria: Inclusion Criteria:

* Squamous cell carcinomas of the oropharynx (OPSCC) candidates for surgical
* Age \> 18 years
* ECOG performance status \<_ 2
* Signature of informed consent (to participate in the study and data processing)

Exclusion Criteria:

* Presence of distant metastases at the time of diagnosis
* Previous head and neck cancer

Primary outcomes:
measure: Observe the kinetics of HPV-DNA levels circulating in the blood
timeFrame: 24 months
Secondary outcomes:
measure: Immuno-phenotyping at the tissue and blood level
timeFrame: 24 months
measure: Isolation of extracellular vesicles
timeFrame: 24 months
Other outcomes:
Locations:
city: Rome
country: Italy
facility: IRCCS National Cancer Institute "Regina Elena"
Study officials:
References: