Actively Recruiting
Study of the Contribution of Mutant p53/YAP Proteins to Therapy Resistance in Recurrent Head and Neck Cancer
Led by Regina Elena Cancer Institute · Updated on 2025-01-24
18
Participants Needed
1
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Researchers are studying head and neck tumors, specifically focusing on the role of mutated p53 and YAP proteins in therapy resistance and local recurrence. This observational study aims to understand molecular networks linked to these mutations in squamous cell tumors of the oral cavity, pharynx, or larynx, with the goal of identifying factors involved in treatment resistance and developing new therapeutic strategies. The study involves analyzing tissue samples collected from patients, both retrospectively and prospectively. Techniques include studying RNA expression profiles, mutational profiles using next-generation sequencing, and single-cell RNA sequencing. Organoid cultures derived from tumor tissues will be used to evaluate treatment responses, and in vivo models will help assess therapy effectiveness. The research compares primary tumor tissues to relapse samples to better understand resistance mechanisms. Participants will provide tissue samples and follow-up data, with at least one year of follow-up for retrospective participants. Researchers will analyze molecular profiles and monitor treatment responses in organoid cultures over 60 months. The study also includes evaluation of molecular networks linked to recurrence timing. Participation involves tissue collection, data review, and laboratory analyses without intervention, lasting up to several years.
CONDITIONS
Brief Title
Study of the Contribution of Mutant p53/YAP Proteins to Therapy Resistance in Recurrent Head and Neck Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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)
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Varies based on sample availability
Participants provide tissue samples from both the primary tumor and the respective relapse for molecular and genetic analyses.
1 to 2 visits depending on tissue collection
Duration - Up to 60 months
Organoids are cultured from participant tumor samples to evaluate response to various treatments by analyzing organoid size and number before and after treatment.
Visits occur as needed for sample collection; lab-based analysis is performed on collected samples
Duration - Up to 60 months
Participants' molecular networks and treatment resistance are observed over time to identify relationships with tumor recurrence and therapy response.
Follow-up visits as needed depending on cohort assignment
Trial Site Locations
Total: 1 location
1
IRCCS National Cancer institute
Roma, Rome, Italy, 00144
Actively Recruiting
Research Team
G
Giovanni Blandino, Doctor
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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