Head and Neck Squamous Cell CarcinomaNCT06905145
Molecular-Based Selection of Patients with Head and Neck Squamous Cell Carcinoma: Biomarker Analysis
An observational study of Head and Neck Squamous Cell Carcinoma and Locally Advanced Stage, run by National Cancer Institute, Naples at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Squamous Cell Carcinoma, Locally Advanced Stage
- What is being tested?
- Biomarkers evaluation
- How many people
- 128 participants
- Where
- 1 siteItaly
- Study dates
- 3 May 2024to May 2032
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older 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
Who may be able to join
- 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.
Who cannot join
- Recurrent/metastatic disease
- Presence of a synchronous second tumor
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Istituto Nazionale Tumori | "Fondazione Pascale"
Naples, 80131
Francesco MD Perri, 0117770403, f.perri@istitutumori.na.it
About this study
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.
Read the 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.
- Being tested
- Biomarkers evaluation
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biomarkers evaluationOther
Evaluate the prognostic role of the markers TP53, P16, Cyclin D1, EGFR, Akt, PDL-1, ERCC1 examined on biopsy samples.
| Study group | Role | What they receive |
|---|---|---|
| Group A: Patients undergoing surgery followed by chemo-radiotherapy | Not described Receives: Other: Biomarkers evaluation | |
| Group B: Patients undergoing exclusive chemo-radiotherapy with CDDP, CBDCA, or Cetuximab | Not described Receives: Other: Biomarkers evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of P53 Expression in Tumor Tissue in Groups A and B
Measured: 84 months
Secondary outcomes (2)
Overall Survival (OS)
Describe the Overall Survival (OS) outcomes obtained in both Groups under observation.
Measured: 84 monhts
Association between Overall Survival (OS) and the expression of biomarkers
Define the association between Overall Survival (OS) and the expression of biomarkers (TP53, P16, Cyclin D1, EGFR, Akt, PDL-1, ERCC1) in both Groups under observation.
Measured: 84 monhts
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2025
- Study start3 May 2024
- Primary completionMay 2026 (estimated)
- Study completionMay 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck Squamous Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute, Naples
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Francesco Perri, MD, Principal investigator, IRCCS I.N.T. "G. Pascale"
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06905145
- Sponsor's protocol ID
- MATEs
- Status last verified
- Mar 2025
- First submitted
- 18 Mar 2025
- Last updated
- 1 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular-Based Selection of Patients with Head and Neck Squamous Cell Carcinoma: Biomarker Analysis
- ClinicalTrials.gov ID
- NCT06905145
- Acronym / sponsor ID
- MATEs
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- National Cancer Institute, NaplesUniversity, hospital or other
- Study start
- 3 May 2024 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- May 2032 (estimated)
- First posted
- 1 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older 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
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- Recurrent/metastatic disease
- Presence of a synchronous second tumor
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biomarkers evaluationEvaluate the prognostic role of the markers TP53, P16, Cyclin D1, EGFR, Akt, PDL-1, ERCC1 examined on biopsy samples. | Other | Group A: Patients undergoing surgery followed by chemo-radiotherapy, Group B: Patients undergoing exclusive chemo-radiotherapy with CDDP, CBDCA, or Cetuximab |
Primary outcome
Percentage of P53 Expression in Tumor Tissue in Groups A and B
Time frame: 84 months
2 secondary outcomes
Overall Survival (OS)
Time frame: 84 monhts
Association between Overall Survival (OS) and the expression of biomarkers
Time frame: 84 monhts
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Francesco Perri, MD principal investigator
IRCCS I.N.T. "G. Pascale"
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Head and Neck Squamous Cell Carcinoma and Locally Advanced Stage, run by National Cancer Institute, Naples at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Francesco Perri, MD (08117770403, f.perri@istitutotumori.na.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of P53 Expression in Tumor Tissue in Groups A and B (time frame: 84 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2025.