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Patients with Human Papillomavirus-associated Head and Neck Cancer for the Discovery of Predictive Biomarkers to Guide Clinical Intervention

R

Regina Elena Cancer Institute

Status

Enrolling

Conditions

Squamous Cell Carcinoma of Oropharynx

Study type

Observational

Funder types

Other

Identifiers

NCT06821243
RS193/IRE/24

Details and patient eligibility

About

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

Full 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.

Enrollment

40 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

1

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Central trial contact

Antonello Vidiri, Medical Doctor

Data sourced from clinicaltrials.gov

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