NCT07692360Not yet recruiting
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 · Last updated 9 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 38 (estimated)
- First submitted
- 2 Jul 2026
- Start date
- 1 Sept 2026
- Primary completion date
- 31 May 2028
- Lead sponsor
- University of Pavia
- Diseases
- Head and neck cancer
- NCT number
- NCT07692360
What you commit to
- Study type: Observational
- Planned participants: 38
- From 1 Sept 2026 to the primary completion date, 31 May 2028
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous OSCC-specific oncological treatment before saliva sample collection
- Acute infection at the time of sampling or within the previous 2 weeks
- 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
- 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
Other illness
- Active or inadequately controlled systemic autoimmune or inflammatory disease that may significantly alter cytokine profiles
- Clinically significant acute oral infection or inflammatory process at the time of sampling
Age
- Age younger than 18 years
Other
- Oral squamous cell carcinoma involving oropharyngeal sites
- Presence of distant metastasis
- Inability to provide written informed consent
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Maxillo-Facial Surgery and Dental Unit, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia Coordinator of this site? Confirm its status | Pavia | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.