Study of the Contribution of Mutant p53/YAP Proteins to T... | NCT06791941

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

NCT06791941

Sponsor

Regina Elena Cancer Institute

Status

Recruiting

Last Update Posted

Jan 24, 2025Actual

Enrollment

18Estimated

Phase

Not provided

Conditions

Head and Neck Tumors

Interventions

Culture of organoids

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 7, 2024Actual

Primary Completion Date

Mar 7, 2029Estimated

Completion Date

Mar 7, 2029Estimated

First Submitted Date

Jan 16, 2025

First Submission Date that Met QC Criteria

Jan 23, 2025

First Posted Date

Jan 24, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 23, 2025

Last Update Posted Date

Jan 24, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

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:

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
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).
Identify the best treatment combinations able to target the networks identified as associated with resistance (prospective cohort).
To evaluate the response of treatments in vivo using a syngeneic model of head and neck tumors HNSCC (MOC model).

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

12 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

18Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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,

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with head and neck tumors

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Giovanni Blandino, Doctor	Contact	+39 06 52662911		giovanni.balndino@ifo.it

Overall Officials

Name	Affiliation	Role
Giovanni Blandino, Doctor	IRCCS National Cancer Institute	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
IRCCS National Cancer institute	Recruiting	Roma	Rome	00144	Italy

Condition Browse Module

MeSH Terms

ID	Term
D006258	Head and Neck Neoplasms

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

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