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

NCT ID: NCT06821243

Last Updated: 2025-02-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-07-24

Study Completion Date

2026-07-24

Brief Summary

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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

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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.

Conditions

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Squamous Cell Carcinoma of Oropharynx

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Università della Campania Luigi Vanvitelli

UNKNOWN

Sponsor Role collaborator

Università di Napoli Federico II

UNKNOWN

Sponsor Role collaborator

I.R.C.C.S. Fondazione Santa Lucia, Italy

UNKNOWN

Sponsor Role collaborator

Regina Elena Cancer Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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IRCCS National Cancer Institute "Regina Elena"

Rome, Rome, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Antonello Vidiri, Medical Doctor

Role: CONTACT

+39 0652665071 ext. +39

Facility Contacts

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Antonello Vidiri, Medical Doctor

Role: primary

+39 0652665071 ext. +39

Other Identifiers

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RS193/IRE/24

Identifier Type: -

Identifier Source: org_study_id

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