Clinical trial · Observational
Molecular-Based Selection of Patients with Head and Neck Squamous Cell Carcinoma: Biomarker Analysis
NCT06905145CI-TRIAL-00087927recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Squamous Cell Carcinoma | Head and Neck Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Locally Advanced Stage | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biomarkers evaluation | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Group A: Patients undergoing surgery followed by chemo-radiotherapy
- interventionNames
- Other: Biomarkers evaluation
- label
- Group B: Patients undergoing exclusive chemo-radiotherapy with CDDP, CBDCA, or Cetuximab
- interventionNames
- Other: Biomarkers evaluation
Primary outcomes (1)
- measure
- Percentage of P53 Expression in Tumor Tissue in Groups A and B
- timeFrame
- 84 months
Secondary outcomes (2)
- measure
- Overall Survival (OS)
- timeFrame
- 84 monhts
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients aged \> 18 years 2. Written informed consent approved by the competent Independent Ethics Committee 3. 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 4. Locally advanced stage: from T1N1M0 to T4N3M0 5. Availability of a tissue sample from a biopsy performed according to clinical practice guidelines. Exclusion Criteria: 1. Recurrent/metastatic disease 2. Presence of a synchronous second tumor
References
Publications (0)
Data not yet available
No reference posted for this study.