Clinical trial · Observational
Analysis of HPV and Biomarkers Present in the Biological Fluids of Patients Suffering From Head and Neck Cancer as a Non-invasive Strategy for Detecting Recurrence
NCT06224166CI-TRIAL-00073325unknownClinicalTrials.gov clinicaltrialsProvenance
- 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)
Multicenter, non-interventional, retrospective/prospective biological study on patients affected by head and neck tumors, for which the collection and use of tissue samples, blood and saliva for the detection of HPV-DNA/RNA and miRNA.
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 |
|---|---|---|---|
| Head and Neck Tumors | Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Collection and use of tissue samples, blood and saliva | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Identification of biomarkers
- timeFrame
- 24 months
- description
- The samples that will be collected in this study will be used to carry out nucleic acid extraction. In particular, the extraction of RNA and DNA from tissue samples will be carried out using the "All prep RNA/DNA miRNA universal kit" kit (Qiagen), while from blood and saliva samples it will be carried out respectively through the use of the "DNAeasy blood and tissue kit" (Qiagen) and the "Magmax Total RNA extraction kit" (Thermofisher), following the instructions given in the relevant protocol. The expression of tissue and circulating microRNAs will be evaluated by qRT-PCR analysis using the Taqman method (Life Technology), digital-PCR (dPCR) and Luminex platform (the latter at the IRCSS G Paolo II Tumor Institute of Bari). In particular, the use of dPCR will be necessary for those low-abundance circulating miRNAs which, with the qRT-PCR methodology, are not detectable.
Secondary outcomes (2)
- measure
- Evaluate HPV-DNA expression as biomarkers.
- timeFrame
- 24 months
- description
- The DNA will be used to detect the presence of HPV and will be analyzed using dPCR and the Luminex platform. These methods are able to absolutely quantify the number of viral genomes present in the sample and also to evaluate the physical state of the virus: episomal, integrated or mixed..
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age over 18 years * Patients suffering from squamous cell tumors of the oral cavity, pharynx or larynx * Surgical patients with HNSCC primary tumors, who have not had previous tumors in other sites or adjuvant treatments prior to surgery. * Availability of material (tissue) and follow-up data for at least one year (retrospective part) * Written informed consent (prospective part/patients in follow-up Exclusion Criteria: * Presence of distant metastases at the time of diagnosis * Previous head and neck cancer+ * Second cancer under treatment or follow-up for less than 5 years
References
Publications (0)
Data not yet available
No reference posted for this study.