Salivary IL-6 and Interleukin Gene Polymorphisms in Oral Squamous Cell Carcinoma

NCT07692360 · tracked via the Priya Life Science Italy tracker

Sponsor

University of Pavia

Phase

Observational

Started

2026-09-01

Last updated

2026-07-09

Condition(s) studied

Oral Squamous Cell Carcinoma (OSCC)

Investigational drug(s) / intervention(s)

Saliva Collection and Biomarker Analysis

Saliva Collection and Biomarker Analysis: Participants will undergo saliva sample collection using a sterile disposable absorbent salivary swab before any OSCC-specific oncological treatment. Salivary samples will be analyzed 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. No experimental treatment will be administered, and the study procedures will not modify the standard diagnostic or therapeutic pathway.

Study summary

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Difference in Salivary Interleukin-6 Levels Between OSCC N0M0 and OSCC N+M0 Patients — Baseline, before any OSCC-specific oncological treatment
Salivary interleukin-6 levels will be compared between patients with oral squamous cell carcinoma without regional lymph node metastasis, classified as OSCC N0M0, and patients with oral squamous cell carcinoma with regional lymph node metastasis, classified as OSCC N+M0. Salivary interleukin-6 will be measured from saliva samples collected using sterile absorbent swabs and expressed as a continuous variable in pg/mL.

Trial sites (2)

Facility	City	Region	Status
Maxillo-Facial Surgery and Dental Unit, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico	Milan	Lombardy
Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia	Pavia	Lombardy

More University of Pavia trials in Italy

Effects of Blood Flow Restriction Combined With Electrostimulation After Knee Arthroplasty Active, not recruiting

Efficacy of Transverse Maxillary Expansion With AMCOP Preformed Appliances Enrolling by invitation

Understanding Alpha-Synuclein Spread in Parkinson's Disease Through Blood Biomarkers and Neuroimaging Starting soon

Comparison of Digital Analysis and Artificial Intelligence for Cephalometric Tracing Recruiting

Adjunctive Periodontal Treatment With Coenzyme Q10 in Association With Probiotics for Pregnant Women Enrolling by invitation

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07692360 on ClinicalTrials.gov ↗ ← All trials in Italy