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

NCT06791941 | Recruiting

• 1 other identifier: RS105/IRE/24
• Study Type: observational
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Head and Neck Tumors

Keywords

head and neck tumors; TP53; organoids

Outcome Measures

Primary Outcomes (1)

• Organoids cultures

  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.

  60 months

Interventions

Culture of organoids BIOLOGICAL

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,

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with head and neck tumors

You may qualify if:

• 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 may not qualify if:

• 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

Sponsors & Collaborators

• Regina Elena Cancer Institute: lead

Study Sites (1)

IRCCS National Cancer institute

Roma, Rome, 00144, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Extraction of RNA and DNA from fresh tissue samples, and paraffin-embedded tissue

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Officials

• Giovanni Blandino, Doctor

  IRCCS National Cancer Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Giovanni Blandino, Doctor

CONTACT

+39 06 52662911; giovanni.balndino@ifo.it

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2025
• First Posted: January 24, 2025
• Study Start: March 7, 2024
• Primary Completion (Estimated): March 7, 2029
• Study Completion (Estimated): March 7, 2029
• Last Updated: January 24, 2025

Record last verified: 2025-01

Locations

IT (1)