NCT06905145 Molecular-Based Selection of Patients with Head and Neck Squamous Cell Carcinoma: Biomarker Analysis
| NCT ID | NCT06905145 |
| Status | Recruiting |
| Phase | — |
| Sponsor | National Cancer Institute, Naples |
| Condition | Head and Neck Squamous Cell Carcinoma |
| Study Type | OBSERVATIONAL |
| Enrollment | 128 participants |
| Start Date | 2024-05-03 |
| Primary Completion | 2026-05 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 128 participants in total. It began in 2024-05-03 with a primary completion date of 2026-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is an observational, prospective study enrolling patients who meet the inclusion criteria and provide consent for the use of biopsy samples collected as part of standard clinical practice. The analysis will focus on the following biomarkers: TP53, P16, Cyclin D1, EGFR, Akt, PDL-1, and ERCC1. These biomarkers will be examined in both observation groups.
Eligibility Criteria
Inclusion Criteria: 1. Patients aged \> 18 years 2. Written informed consent approved by the competent Independent Ethics Committee 3. Histopathological diagnosis of squamous cell carcinoma of the head and neck region originating from one of the following organs or structures: Oral cavity, oropharynx, larynx, hypopharynx 4. Locally advanced stage: from T1N1M0 to T4N3M0 5. Availability of a tissue sample from a biopsy performed according to clinical practice guidelines. Exclusion Criteria: 1. Recurrent/metastatic disease 2. Presence of a synchronous second tumor
Contact & Investigator
Francesco Perri, MD
PRINCIPAL INVESTIGATOR
IRCCS I.N.T. "G. Pascale"
Frequently Asked Questions
Who can join the NCT06905145 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Head and Neck Squamous Cell Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06905145 currently recruiting?
Yes, NCT06905145 is actively recruiting participants. Contact the research team at f.perri@istitutotumori.na.it for enrollment information.
Where is the NCT06905145 trial being conducted?
This trial is being conducted at Naples, Italy.
Who is sponsoring the NCT06905145 clinical trial?
NCT06905145 is sponsored by National Cancer Institute, Naples. The principal investigator is Francesco Perri, MD at IRCCS I.N.T. "G. Pascale". The trial plans to enroll 128 participants.