NCT07915570Recruiting
Salivary IL-8 and Serum IL-6 as Biomarkers for Oral Potentially Malignant Disorders in Smokers and Never-Smokers
Diagnostic Performance of Salivary Interleukin-8 and Serum Interleukin-6 for Oral Potentially Malignant Disorders: Effect Modification by Smoking Status - A Cross-Sectional Study
Source: ClinicalTrials.gov · Last updated 4 Nov 2026
Brief summary (registry, in English)
The goal of this observational study is to learn whether two inflammatory proteins, interleukin-8 (IL-8) measured in saliva and interleukin-6 (IL-6) measured in blood serum, can help distinguish adults with oral potentially malignant disorders (OPMDs), such as oral lichen planus and leukoplakia, from adults with healthy oral mucosa, and whether smoking changes these protein levels. The main questions it aims to answer are: * Do salivary IL-8 and serum IL-6 levels differ between people with OPMDs and healthy controls, and does this difference depend on smoking status? * How well do IL-8 and IL-6, alone or combined, discriminate people with OPMDs from healthy controls? Researchers compared healthy never-smokers, healthy current smokers, never-smokers with OPMDs, and current smokers with OPMDs. An additional exploratory group of current smokers with oral squamous cell carcinoma (OSCC) was compared with current smokers with OPMDs. Participants provided an unstimulated whole saliva sample and a blood sample at a single visit, and completed a clinical, periodontal, and tobacco-use assessment. No treatment was assigned as part of the study.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 250 (estimated)
- First submitted
- 15 Oct 2026
- Start date
- 1 Oct 2026
- Primary completion date
- 30 Dec 2026
- Lead sponsor
- British University In Egypt
- Diseases
- Head and neck cancer
- NCT number
- NCT07915570
What you commit to
- Study type: Observational
- Planned participants: 250
- From 1 Oct 2026 to the primary completion date, 30 Dec 2026
- 1 site 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 design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Recent major dental surgery or invasive dental procedure
- Current systemic treatment likely to substantially affect inflammatory cytokine concentrations (e.g., systemic corticosteroids or immunomodulatory agents)
Other illness
- Active oral infection unrelated to the study lesion
- Active or recent systemic infection
- Uncontrolled diabetes mellitus
- Major systemic inflammatory or autoimmune disease
Lab values
- Biological samples insufficient, unsuitable for analysis, or failing predefined laboratory quality-control criteria
Other
- Clinically significant salivary gland dysfunction
- Essential clinical data or smoking-status classification unavailable
Who the study is looking for
- All participants:
- Age 18 years or older
- Written informed consent provided before enrollment
- Smoking status classifiable as never-smoker or current smoker
- Healthy controls:
- Clinically healthy oral mucosa
- No clinical evidence or previous history of oral potentially malignant disorders (OPMDs) or oral cancer
- OPMD group:
- Clinically identified oral lichen planus or oral leukoplakia, confirmed histopathologically
- No definitive treatment of the lesion before biological-sample collection
- OSCC group (exploratory):
- Histopathologically confirmed oral squamous cell carcinoma
- Current smoker
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The British University in Egypt Coordinator of this site? Confirm its status | Cairo | Egypt | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.