NCT07692360

Brief 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for all trials

Timeline
22mo left

Started Sep 2026

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 2, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 9, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2028

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2028

Last Updated

July 9, 2026

Status Verified

July 1, 2026

Enrollment Period

1.7 years

First QC Date

July 2, 2026

Last Update Submit

July 2, 2026

Conditions

Oral Squamous Cell Carcinoma (OSCC)

Keywords

Oral squamous cell carcinomaOSCCSalivary interleukin-6IL-6Interleukin gene polymorphismsRegional lymph node metastasisLocoregional progressionSalivary biomarkersGenetic biomarkersIL6IL1BIL10IL8CXCL8IL1RNTumor microenvironment

Outcome Measures

Primary Outcomes (1)

  • Difference in Salivary Interleukin-6 Levels Between OSCC N0M0 and OSCC N+M0 Patients

    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 Outcomes (2)

  • Association Between Regional Lymph Node Status and Interleukin Gene Polymorphisms

    Baseline, before any OSCC-specific oncological treatment

  • Association Between Interleukin Gene Polymorphisms and Salivary Interleukin-6 Levels

    Baseline, before any OSCC-specific oncological treatment

Study Arms (2)

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

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

Interventions

Saliva Collection and Biomarker AnalysisOTHER

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.

Also known as: Salivary IL-6 Measurement; Interleukin Gene Polymorphism Analysis
OSCC N+M0OSCC N0M0

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Maxillo-Facial Surgery and Dental Unit, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

Milan, Lombardy, 20122, Italy

Location

Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia

Pavia, Lombardy, 27100, Italy

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Saliva samples will be collected using sterile disposable absorbent salivary swabs. Samples will be used for the planned measurement of salivary interleukin-6 levels and for the analysis of selected interleukin gene polymorphisms from available biological material. No biospecimens will be retained for future unspecified research or biobanking after completion of the planned laboratory analyses.

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

Carcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsHead and Neck NeoplasmsNeoplasms by Site

Central Study Contacts

Matteo Pellegrini, DDS

CONTACT

+39 0382 516209matteo.pellegrini02@universitadipavia.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Principal Investigator

Study Record Dates

First Submitted

July 2, 2026

First Posted

July 9, 2026

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

May 31, 2028

Study Completion (Estimated)

June 30, 2028

Last Updated

July 9, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

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

Locations

IT(2)