Clinical trial · Observational
Observational Study of Viral BIOmarkers and microRNAs in Tumors Orofarynx and Occult Tumors Positive for Papilloma Virus
- 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)
Based on the evidence summarized in the introduction, the clinician hypothesize that the detection of the presence and expression of HPV-DNA, certain miRNAs, and a certain mutational profile in the tissues and biological fluids of these patients, may have important prognostic and diagnostic value not only in HPV-related OPSCCs but also in HPV+ occult T. Accordingly, this study aims to aim to better characterize their potential as biomarkers and to detect the possibility of their their use to implement the sensitivity and specificity of radiological methodologies (PET-CT and MRI), already in use in clinical practice, for monitoring disease progression in this specific subgroup. Finally, by using the collected material to generate organoids and Patient Derived Xenograft (PDX), the study also aims to identify possible new molecular drugs, which could solve the problem of resistance to radiochemotherapy.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinomas of Unknown Primary Site | — | UNRESOLVED | — |
| High-risk Human Papillomavirus Infection | — | UNRESOLVED | — |
| Liquid Biopsy | — | UNRESOLVED | — |
| Lymph Node Metastasis | — | UNRESOLVED | — |
| Occult Tumor of the Head and Neck Area | — | UNRESOLVED | — |
| Squamous Cell Carcinoma of the Oropharynx | Oropharyngeal Squamous Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Study of Viral BIOmarkers and microRNAs in Tumors Orofarynx | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Group 1
- description
- High miR value
- interventionNames
- Diagnostic Test: Study of Viral BIOmarkers and microRNAs in Tumors Orofarynx
- label
- Group 2
- description
- Control group
- interventionNames
- Diagnostic Test: Study of Viral BIOmarkers and microRNAs in Tumors Orofarynx
Primary outcomes (1)
- measure
- Accouracy
- timeFrame
- Baseline
- description
- Investigating the kinetics of HPV-DNA and miRNAs in patients with oropharyngeal and occult T tumors with laterocervical metastasis. Conducting this study will allow us to collect the information needed to be able to generate hypotheses and design a subsequent larger study.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Squamous cell carcinomas of the oropharynx and occult neoplasms with lymph node metastases laterocervical cytologically positive for squamous cell carcinoma treated with TORS or RT or RT/CT * Age \> 18 years * ECOG performance status \<\_ 2 * Ability to follow study procedures and complete questionnaires * Signature of informed consent Exclusion Criteria: * Presence of distant metastases at the time of diagnosis * Previous cancer of the head and neck district * Second tumor in therapy or follow-up for less than 5 years
References
Publications (0)
Data not yet available