Salivary IL-6 and Interleukin Gene Polymorphisms in Oral Squamous Cell Carcinoma (NCT07692360) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Salivary IL-6 and Interleukin Gene Polymorphisms in Oral Squamous Cell Carcinoma
Italy38 participantsStarted 2026-09-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Difference in Salivary Interleukin-6 Levels Between OSCC N0M0 and OSCC N+M0 Patients
Timeframe: Baseline, before any OSCC-specific oncological treatment