Clinical trial · Observational
Salivary IL-6 and Interleukin Gene Polymorphisms in Oral Squamous Cell Carcinoma
Salivary Interleukin-6 Levels and Interleukin Gene Polymorphisms for the Biological Stratification of Locoregional Progression in Oral Squamous Cell Carcinoma (OSCC): A Multicentre Observational Cross-Sectional Study
- 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 observational study will evaluate whether salivary interleukin-6 levels and selected interleukin gene polymorphisms are associated with regional lymph node involvement in patients with oral squamous cell carcinoma. Adult patients with histologically confirmed oral squamous cell carcinoma will be enrolled before receiving any cancer-specific treatment. Participants will be classified into two groups according to the presence or absence of regional lymph node metastasis: OSCC N0M0 and OSCC N+M0. The study does not involve any experimental treatment and does not change the standard diagnostic or therapeutic pathway. Each participant will provide a saliva sample using a sterile absorbent swab. The saliva sample will be used to measure interleukin-6 levels. Available biological material will also be used to analyze selected interleukin gene polymorphisms, including IL6, IL1B, IL10, IL8/CXCL8, and IL1RN. The aim of the study is to explore whether these salivary and genetic markers may help characterize different biological patterns of locoregional progression in oral squamous cell carcinoma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Oral Squamous Cell Carcinoma (OSCC) | Oral Cavity Squamous Cell Carcinoma | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Saliva Collection and Biomarker Analysis | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- OSCC N0M0
- description
- Adult patients with histologically confirmed oral squamous cell carcinoma of the oral cavity, without regional lymph node metastasis and without distant metastasis. Participants will undergo saliva sample collection before any OSCC-specific oncological treatment. No experimental intervention will be administered.
- interventionNames
- Other: Saliva Collection and Biomarker Analysis
- label
- OSCC N+M0
- description
- Adult patients with histologically confirmed oral squamous cell carcinoma of the oral cavity, with regional lymph node metastasis and without distant metastasis. Participants will undergo saliva sample collection before any OSCC-specific oncological treatment. No experimental intervention will be administered.
- interventionNames
- Other: Saliva Collection and Biomarker Analysis
Primary outcomes (1)
- measure
- Difference in Salivary Interleukin-6 Levels Between OSCC N0M0 and OSCC N+M0 Patients
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age 18 years or older * Histopathologically confirmed diagnosis of oral squamous cell carcinoma of the oral cavity * Oral squamous cell carcinoma site excluding oropharyngeal sites * Defined regional lymph node status allowing classification as OSCC N0M0 or OSCC N+M0 * Absence of distant metastasis, classified as M0 * Saliva sample collection feasible before any OSCC-specific oncological treatment, including surgery, radiotherapy, chemotherapy, immunotherapy, or targeted therapy * Suitability for saliva collection using a standardized absorbent swab * Availability of biological material for genotyping * Ability to provide written informed consent for study participation, biological sampling, and genetic analysis Exclusion Criteria: * Age younger than 18 years * Oral squamous cell carcinoma involving oropharyngeal sites * Presence of distant metastasis * Previous OSCC-specific oncological treatment before saliva sample collection * Acute infection at the time of sampling or within the previous 2 weeks * Active or inadequately controlled systemic autoimmune or inflammatory disease that may significantly alter cytokine profiles * Systemic immunosuppressive or immunomodulatory therapy within the previous 4 to 8 weeks * Recent oncological treatment for malignancies other than OSCC within the previous 6 months, if considered potentially interfering with the immune-inflammatory profile * Clinically significant acute oral infection or inflammatory process at the time of sampling * Active oral bleeding or evident blood contamination of the salivary swab Invasive dental procedures within the previous 2 weeks * Systemic antibiotic therapy within the previous 2 weeks * Inability to provide written informed consent
References
Publications (0)
Data not yet available