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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

18 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-03-07

Study Completion Date

2029-03-07

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Molecular-Based Selection of Patients with Head and Neck Squamous Cell Carcinoma: Biomarker Analysis

NCT06905145

Head and Neck Squamous Cell Carcinoma Locally Advanced Stage

RECRUITING

Patients with Human Papillomavirus-associated Head and Neck Cancer for the Discovery of Predictive Biomarkers to Guide Clinical Intervention

NCT06821243

Squamous Cell Carcinoma of Oropharynx

RECRUITING

Preoperative TPF Chemotherapy in Molecularly Selected Locally Advanced Resectable Oral Cavity Squamous Cell Cancer

NCT01914900

Locally Advanced Resectable Oral Cavity Squamous Cell Cancer

COMPLETED PHASE2

The Head and Neck Registry of the European Reference Network on Rare Adult Solid Cancers

NCT05483374

Head and Neck Cancer Nasopharynx Cancer Nasal Cavity and Paranasal Sinus Cancer +2 more

RECRUITING

Analysis of HPV and Biomarkers Present in the Biological Fluids of Patients Suffering From Head and Neck Cancer as a Non-invasive Strategy for Detecting Recurrence

NCT06224166

Head and Neck Tumors

RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The study aims to characterize molecular networks governed by the mutated protein p53 with a relevant role in the development of local recurrence in head and neck tumors HNSCC, in order to identify the main actors involved in resistance to current therapy and try to develop new more effective therapeutic strategies for head and neck tumors.

Furthermore, the existence of a significant relationship between the time of onset of recurrence and the deregulation of the identified molecular networks will be studied.

This study will therefore allow to:

1. Identify networks associated with the presence of mutation in the TP53 gene relevant in the development of relapse, comparing the tissues of the primary tumor to the respective tissue of the relapse of patients affected by head and neck cancer, by:

1. expression profiles of coding and non-coding RNAs (retrospective cohort)
2. mutational profile by NGS (retrospective cohort)
3. Single cell RNA-sequencing (SC-RNAseq) on samples belonging to the prospective cohort
2. Characterize the molecular mechanisms underlying TP53-dependent networks with a key role in resistance to therapy, using resistance cell systems and in organoid cultures derived from head and neck tumors HNSCC (PDO) (prospective cohort).
3. Identify the best treatment combinations able to target the networks identified as associated with resistance (prospective cohort).
4. To evaluate the response of treatments in vivo using a syngeneic model of head and neck tumors HNSCC (MOC model).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Head and Neck Tumors

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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,

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No