Salivary IL-6 and Interleukin Gene Polymorphisms in Oral Squamous Cell Carcinoma (IL6-OSCC)

July 2, 2026 updated by: Andrea Scribante, University of Pavia

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Oral squamous cell carcinoma is characterized by variable biological behavior, including different patterns of regional lymph node involvement. Regional lymph node metastasis is one of the main prognostic factors in this disease. However, patients with similar clinicopathological characteristics may show different patterns of locoregional progression, suggesting that additional biological markers may help describe tumor behavior.

This multicentre observational cross-sectional study will investigate salivary interleukin-6 and selected interleukin gene polymorphisms in adult patients with histologically confirmed oral squamous cell carcinoma. Participants will be enrolled before any cancer-specific treatment and classified according to regional lymph node status as OSCC N0M0 or OSCC N+M0.

Saliva will be collected using a standardized sterile absorbent swab procedure. Salivary interleukin-6 levels will be quantified and expressed as pg/mL. Selected interleukin-related genetic polymorphisms, including IL6, IL1B, IL10, IL8/CXCL8, and IL1RN, will be analyzed from available biological material using validated molecular biology methods.

The primary objective is to compare salivary interleukin-6 levels between patients without regional lymph node metastasis and patients with regional lymph node metastasis. Secondary objectives include evaluating the association between nodal status and interleukin gene polymorphisms, and exploring the relationship between these polymorphisms and salivary interleukin-6 levels.

No experimental treatment will be administered, and participation will not modify the standard diagnostic or therapeutic management of oral squamous cell carcinoma.

Study Type

Observational

Enrollment (Estimated)

38

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
    • Lombardy
      • Milan, Lombardy, Italy, 20122
        • Maxillo-Facial Surgery and Dental Unit, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
        • Contact:
      • Pavia, Lombardy, Italy, 27100
        • Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population will include adult patients with histopathologically confirmed oral squamous cell carcinoma of the oral cavity, enrolled before any OSCC-specific oncological treatment. Participants will be classified according to regional lymph node status into two observational cohorts: OSCC N0M0, defined as absence of regional lymph node metastasis and absence of distant metastasis, and OSCC N+M0, defined as presence of regional lymph node metastasis and absence of distant metastasis. Patients will be recruited from participating Italian study centres involved in the clinical management of oral squamous cell carcinoma.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
OSCC N0M0
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.
Other: 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.
Other Names:
  • Salivary IL-6 Measurement; Interleukin Gene Polymorphism Analysis
OSCC N+M0
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.
Other: 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.
Other Names:
  • Salivary IL-6 Measurement; Interleukin Gene Polymorphism Analysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in Salivary Interleukin-6 Levels Between OSCC N0M0 and OSCC N+M0 Patients
Time Frame: 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.
Baseline, before any OSCC-specific oncological treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Association Between Regional Lymph Node Status and Interleukin Gene Polymorphisms
Time Frame: Baseline, before any OSCC-specific oncological treatment
The association between regional lymph node status and selected interleukin gene polymorphisms will be evaluated by comparing genotype and/or allele frequencies of IL6, IL1B, IL10, IL8/CXCL8, and IL1RN between patients with OSCC N0M0 and patients with OSCC N+M0. Where appropriate, results will be expressed as odds ratios for regional lymph node metastasis.
Baseline, before any OSCC-specific oncological treatment
Association Between Interleukin Gene Polymorphisms and Salivary Interleukin-6 Levels
Time Frame: Baseline, before any OSCC-specific oncological treatment
The association between selected interleukin gene polymorphisms and salivary interleukin-6 levels will be assessed by comparing salivary interleukin-6 concentrations across genotype groups and/or through regression models using salivary interleukin-6 as a continuous dependent variable. Salivary interleukin-6 will be expressed in pg/mL.
Baseline, before any OSCC-specific oncological treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pavia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

May 31, 2028

Study Completion (Estimated)

June 30, 2028

Study Registration Dates

First Submitted

July 2, 2026

First Submitted That Met QC Criteria

July 2, 2026

First Posted (Actual)

July 9, 2026

Study Record Updates

Last Update Posted (Actual)

July 9, 2026

Last Update Submitted That Met QC Criteria

July 2, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IL6-OSCC-2026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data will be available upon motivated request to the corresponding authors.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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