NCT05918510Recruiting
Observational Study of Viral BIOmarkers and microRNAs in Tumors Orofarynx and Occult Tumors Positive for Papilloma Virus
Source: ClinicalTrials.gov · Last updated 10 Oct 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 142 (estimated)
- First submitted
- 29 Mar 2023
- Start date
- Apr 2022
- Primary completion date
- Apr 2024
- Lead sponsor
- Regina Elena Cancer Institute
- Diseases
- Head and neck cancer
- NCT number
- NCT05918510
What you commit to
- Study type: Observational
- Planned participants: 142
- From Apr 2022 to the primary completion date, Apr 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Second tumor in therapy or follow-up for less than 5 years
Other illness
- Previous cancer of the head and neck district
Other
- Presence of distant metastases at the time of diagnosis
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Regina Elena National Cancer Institute Coordinator of this site? Confirm its status | Rome | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.