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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorRegina Elena Cancer Institute

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

Patients with head and neck tumors

Trial design

Design model

Other

Time perspective

Cross-sectional

Treatments tested in this trial

  • Culture of organoids

    Biological/Vaccine

    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,

Treatment groups

No treatment groups listed

Trial outcomes

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.

Time frame
60 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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