Saliva and gene markers linked to lymph node spread in oral cancer
Studies saliva interleukin-6 and gene variants in adults with oral squamous cell carcinoma.
Plain-language title generated from the registry record
Registry title: Salivary IL-6 and Interleukin Gene Polymorphisms in Oral Squamous Cell Carcinoma
Key facts
- Where
- Milan and Pavia, ItalySee the 2 sites
Where in Italy
- Maxillo-Facial Surgery and Dental Unit, Fondazione IRCCS Cà Granda Ospedale Maggiore PoliclinicoMilan, ItalyNo longer taking part
- Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of PaviaPavia, ItalyNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University of Pavia
- Trial code
- NCT07692360
- Record updated
- 9 July 2026
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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: 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; 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 younger than 18 years; Oral squamous cell carcinoma involving oropharyngeal sites; Presence of distant metastasis; Inability to provide written informed consent.