Molecular-Based Selection of Patients with Head and Neck Squamous Cell Carcinoma: Biomarker Analysis
Launched by NATIONAL CANCER INSTITUTE, NAPLES · Mar 25, 2025
Trial Information
Current as of July 27, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying patients with locally advanced head and neck squamous cell carcinoma, which is a type of cancer that can occur in areas like the mouth and throat. Researchers aim to understand specific biological markers, known as biomarkers, that are present in tumor samples from patients. These biomarkers include TP53, P16, Cyclin D1, EGFR, Akt, PDL-1, and ERCC1. By analyzing these, the study hopes to gain insights that could help in selecting the best treatment options for patients.
To participate in this trial, patients need to be over 18 years old and have a confirmed diagnosis of squamous cell carcinoma in specific areas of the head and neck, with a certain stage of the disease. They should also have a recent tissue sample available from a biopsy. Patients with recurrent cancer or another active tumor cannot join. Those who do participate will help researchers learn more about how these biomarkers affect treatment decisions, contributing valuable information to future cancer care.
Gender
ALL
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
About National Cancer Institute, Naples
The National Cancer Institute (NCI) in Naples is a leading research institution dedicated to advancing the understanding and treatment of cancer through innovative clinical trials. As a prominent sponsor of cancer research, the NCI focuses on developing novel therapies, improving patient outcomes, and exploring cutting-edge methodologies in oncology. With a commitment to scientific rigor and collaboration, the NCI in Naples engages in partnerships with academic institutions and healthcare providers to facilitate groundbreaking studies that address critical challenges in cancer care. Their mission is to translate research findings into effective treatments, ultimately enhancing the lives of patients affected by cancer.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Napoli, , Italy
Patients applied
Trial Officials
Francesco Perri, MD
Principal Investigator
IRCCS I.N.T. "G. Pascale"
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported