Study of the Contribution of Mutant p53/YAP Proteins to Therapy Resistance in Recurrent Head and Neck Cancer

NCT06791941 · tracked via the Priya Life Science Italy tracker

Sponsor

Regina Elena Cancer Institute

Phase

Observational

Started

2024-03-07

Last updated

2025-01-24

Condition(s) studied

Head and Neck Tumors

Investigational drug(s) / intervention(s)

Culture of organoids

Culture of organoids: Culture of organoids prepared from both the primary tumor and the respective relapse, using the material from the prospective part of the study, the response to treatment will be carried out by macroscopic analysis, evaluating the size and number of organoids before and after treatment,

Study summary

Multicenter, non-interventional, retrospective/prospective study of a biological nature, on patients affected by head and neck tumors, for which the collection and use of tissue samples is planned for the study of the mutational profile, the transcriptional profile and the proteomic profile.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Organoids cultures — 60 months
Fresh tissue samples collected from surgery at the reference centers will be selected by the pathologist, and stored at 4°C in special media at the reference laboratories. These samples will be evaluated by means of viabilityassays with ATPlite, the ability to form colonies and apoptosis assays (by FACS). For organoids, the response to treatment will be performed by macroscopic analysis, evaluating the size and number of organoids before and after treatment.

Trial sites (1)

Facility	City	Region	Status
IRCCS National Cancer institute	Roma	Rome	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06791941 on ClinicalTrials.gov ↗ ← All trials in Italy