Clinical trial · Observational
Patients With Human Papillomavirus-associated Head and Neck Cancer for the Discovery of Predictive Biomarkers to Guide Clinical Intervention
Multidimensional Assessment of Virus-associated Head and Neck Cancer Patients for the Discovery of Predictive Biomarkers to Guide Clinical Intervention
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Squamous Cell Carcinoma of Oropharynx | Oropharyngeal Squamous Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Observe the kinetics of HPV-DNA levels circulating in the blood
- timeFrame
- 24 months
- description
- ctHPV DNA levels will be measured by digital PCR, 8 mL of blood will be collected in DNA BCT Streck tubes. The blood will be centrifuged a room temperature and frozen at -80°C until extraction. Total ctDNA will be extracted from 5 mL of plasma using the QIAamp Circulating Nucleic Acid Kit and will be quantified with a Qubit fluorometer. The ddPCR will be performed on a QX-200 platform and analyzed with QuantaSoft software v1.7.4.0917. Probes will be used for conserved regions of HPV E6 for HPV 16. Samples will be run with 5 cfDNA input to 10 ng and titered to optimize ddPCR performance, with a range of 1 to 20 ng of cfDNA total loaded per well. These reactions will be added to a DG8 cartridge along with 60mL of droplet generating oil. The drops will then be transferred to a plate from 96 wells and subjected to thermal cycles with the following conditions: 5 min at 95°C, 40 cycles at 94°C for 30 seconds, 55°C for 1 minute followed by 98°C for 10 min.
Secondary outcomes (2)
- measure
- Immuno-phenotyping at the tissue and blood level
- timeFrame
- 24 months
- description
- Immuno-phenotyping at the tissue and blood level will be performed. Specific T cells for HPV will be identified by detecting the expression of the induced marker by activation (AIM) on the cell surface or by the production of intracellular cytokines, after exposure to HPV-derived peptide pools. AIM+ CD4+ T cells will be defined as positive for the expression of CD40L and CD69, while the expression of CD137 and CD69 will identify the subgroup CD8+ AIM+. The frequency and absolute number of specific CD4+ and CD8+ T cells will be determined HPV. Precise immunophenotyping will be performed using two panels antibodies. Innate immune cells and B lymphocytes will be investigated using a panel specific antibody to obtain a complete view of the patients' immune system
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available