Actively Recruiting

Age: 18Years +
All Genders
ID06791941

Study of Mutant p53 and YAP Proteins' Role in Therapy Resistance in Recurrent Head and Neck Tumors An Observational Molecular and Tissue Analysis Study

Led by Regina Elena Cancer Institute · Updated on 2025-01-24

18

Participants Needed

1

Research Sites

260 weeks

Total Duration

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AI-Summary

What this Trial Is About

Researchers are investigating the role of mutated p53 protein and YAP proteins in causing resistance to therapy in patients with recurrent head and neck tumors. The study focuses on head and neck squamous cell carcinoma (HNSCC) and aims to understand the molecular networks driven by TP53 mutations that contribute to tumor relapse. It also explores the link between the timing of tumor recurrence and changes in these molecular pathways to help develop new treatment strategies. The study collects tissue samples from both the original tumors and their relapses. These samples are analyzed retrospectively for gene expression, mutations through next-generation sequencing, and single-cell RNA sequencing in a prospective cohort. Organoid cultures created from tumor tissues are used to study how tumors resist treatment and to test different drug combinations. Additionally, an in vivo mouse model is employed to evaluate treatment responses. Participants will provide tumor tissue samples and follow-up data for analysis. Researchers will monitor organoid cultures by measuring their size and number before and after treatments. The main outcome is the study of organoid cultures over 60 months. The study includes patients aged 18 years and older with head and neck squamous cell tumors, and it requires adequate tissue samples and at least one year of follow-up data for retrospective cases. Consent is obtained for all participants involved in prospective or retrospective parts of the research.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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)
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

IRCCS National Cancer institute

Roma, Rome, Italy, 00144

Actively Recruiting

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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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