Understanding how mutant p53/YAP proteins affect treatment resistance in head and neck cancer
Study of the Contribution of Mutant p53/YAP Proteins to Therapy Resistance in Recurrent Head and Neck Cancer
Regina Elena Cancer Institute · NCT06791941
This study looks at how changes in certain proteins in head and neck cancer cells might make them resistant to treatment, helping doctors find better ways to fight the disease.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 18 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Regina Elena Cancer Institute (other) |
| Locations | 1 site (Roma, Rome) |
| Trial ID | NCT06791941 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on patients with head and neck tumors to analyze the mutational, transcriptional, and proteomic profiles of their tissue samples. It aims to characterize the molecular networks influenced by the mutated p53 protein, which plays a significant role in local recurrence of head and neck squamous cell carcinoma (HNSCC). By comparing primary tumors to recurrent tissues, the study seeks to identify key factors contributing to therapy resistance and explore potential new treatment strategies. The research includes both retrospective and prospective cohorts, utilizing advanced techniques such as single-cell RNA sequencing and organoid cultures.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with squamous cell tumors of the oral cavity, pharynx, or larynx who have not received prior treatments.
Not a fit: Patients with distant metastases, previous head and neck cancers, or those undergoing treatment for a second cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to the development of more effective therapies for patients with head and neck cancer.
How similar studies have performed: While the approach of studying molecular networks in therapy resistance is established, the specific focus on mutant p53/YAP proteins in head and neck cancer is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age over 18 * Patients with squamous cell tumors of the oral cavity, pharynx or larynx * Surgical patients with primary HNSCC tumors, who have not had previous tumors in other sites or adjuvant treatments prior to surgery. * Availability of adequate material (tissue) for the planned analyses * Availability of follow-up data for at least one year (retrospective part) * Written informed consent (prospective part and/or, for the retrospective part, traceable patients and/or patients in follow-up and/or if necessary for the legal nature/institutional purposes of the participating centers). Exclusion Criteria: * Presence of distant metastases at the time of diagnosis * Previous head and neck cancer * Second cancer undergoing treatment or follow-up for less than 5 years
Where this trial is running
Roma, Rome
- IRCCS National Cancer institute — Roma, Rome, Italy (RECRUITING)
Study contacts
- Principal investigator: Giovanni Blandino, Doctor — IRCCS National Cancer Institute
- Study coordinator: Giovanni Blandino, Doctor
- Email: giovanni.balndino@ifo.it
- Phone: +39 06 52662911
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Head and Neck Tumors, head and neck tumors, TP53, organoids