Molecular-Based Selection of Patients with Head and Neck... | NCT06905145

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

NCT06905145

Sponsor

National Cancer Institute, Naples

Status

Recruiting

Last Update Posted

Apr 1, 2025Actual

Enrollment

128Estimated

Phase

Not provided

Conditions

Head and Neck Squamous Cell Carcinoma
Locally Advanced Stage

Interventions

Biomarkers evaluation

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

Mar 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

May 3, 2024Actual

Primary Completion Date

May 2026Estimated

Completion Date

May 2032Estimated

First Submitted Date

Mar 18, 2025

First Submission Date that Met QC Criteria

Mar 25, 2025

First Posted Date

Apr 1, 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

Mar 25, 2025

Last Update Posted Date

Apr 1, 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

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This is an observational, prospective study enrolling patients who meet the inclusion criteria and provide consent for the use of biopsy samples collected as part of standard clinical practice. The analysis will focus on the following biomarkers: TP53, P16, Cyclin D1, EGFR, Akt, PDL-1, and ERCC1.

These biomarkers will be examined in both observation groups.

Detailed Description

The primary objective of this project is to evaluate the prognostic role of the biomarker P53, as numerous studies suggest its association with poor prognosis. This analysis will be particularly relevant for p16-positive (HPV-related) patients, who are currently considered a good prognosis category. The study aims to determine whether cases with overexpression of both p16 and P53 deviate from this assumption.

A secondary objective is to validate a molecular signature in clinical practice, composed of multiple biomarkers, to assess whether specific combinations can predict treatment response.

The biomarkers TP53, P16, Cyclin D1, EGFR, Akt, PDL-1, and ERCC1 will be analyzed on biopsy samples from patients with newly diagnosed, locally advanced squamous cell carcinoma of the head and neck.

The study population consists of patients with locally advanced Head and Neck Squamous Cell Carcinoma who have an available biopsy sample collected as part of standard clinical practice. The groups will be classified based on the treatment received:

Group A: Patients undergoing surgery followed by chemoradiotherapy.
Group B: Patients receiving exclusive chemoradiotherapy with CDDP, CBDCA, or Cetuximab.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

128Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group A: Patients undergoing surgery followed by chemo-radiotherapy			Other: Biomarkers evaluation
Group B: Patients undergoing exclusive chemo-radiotherapy with CDDP, CBDCA, or Cetuximab			Other: Biomarkers evaluation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Biomarkers evaluation	Other	Evaluate the prognostic role of the markers TP53, P16, Cyclin D1, EGFR, Akt, PDL-1, ERCC1 examined on biopsy samples.	Group A: Patients undergoing surgery followed by chemo-radiotherapy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of P53 Expression in Tumor Tissue in Groups A and B		84 months

Secondary Outcomes

Measure	Description	Time Frame
Overall Survival (OS)	Describe the Overall Survival (OS) outcomes obtained in both Groups under observation.	84 monhts
Association between Overall Survival (OS) and the expression of biomarkers

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients aged > 18 years
Written informed consent approved by the competent Independent Ethics Committee
Histopathological diagnosis of squamous cell carcinoma of the head and neck region originating from one of the following organs or structures: Oral cavity, oropharynx, larynx, hypopharynx
Locally advanced stage: from T1N1M0 to T4N3M0
Availability of a tissue sample from a biopsy performed according to clinical practice guidelines.

Exclusion Criteria:

Recurrent/metastatic disease
Presence of a synchronous second tumor

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

The study population consists of patients with locally advanced Head and Neck Squamous Cell Carcinoma who will have a biopsy sample obtained according to clinical practice. These groups will be divided based on the treatment received:

**Group A**: Patients undergoing surgery followed by chemo-radiotherapy
**Group B**: Patients undergoing exclusive chemo-radiotherapy with CDDP, CBDCA, or Cetuximab

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Francesco Perri, MD	Contact	08117770403		f.perri@istitutotumori.na.it

Overall Officials

Name	Affiliation	Role
Francesco Perri, MD	IRCCS I.N.T. "G. Pascale"	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Istituto Nazionale Tumori \| "Fondazione Pascale"	Recruiting	Naples		80131	Italy

Condition Browse Module

MeSH Terms

ID	Term
D000077195	Squamous Cell Carcinoma of Head and Neck

Ancestor Terms

ID	Term
D002294	Carcinoma, Squamous Cell
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type

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Browse Branches

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