Salivary IL-8 and Serum IL-6 as Biomarkers to Distinguish Oral Premalignant Disorders in Smokers and Never-Smokers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a cross-sectional observational study enrolling 250 adults to see if two inflammatory proteins, IL-8 in saliva and IL-6 in serum, differ between people with oral potentially malignant disorders and healthy controls, and whether smoking status modifies these levels. The primary analysis compares four groups of 50 participants each: healthy never-smokers, healthy current smokers, never-smokers with OPMDs, and current smokers with OPMDs. An exploratory cohort of 50 current smokers with OSCC is analyzed separately. Participants provide saliva and blood samples for biomarker measurement and have detailed dental, smoking, and clinical data collected. Statistical methods include t-tests, nonparametric tests, and regression modeling to assess diagnostic discrimination of IL-8 and IL-6, alone and in combination.

Why it matters

Who can join: the full rules

Inclusion Criteria:

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

Exclusion Criteria:

* Active oral infection unrelated to the study lesion
* Recent major dental surgery or invasive dental procedure
* Active or recent systemic infection
* Uncontrolled diabetes mellitus
* Major systemic inflammatory or autoimmune disease
* Clinically significant salivary gland dysfunction
* Current systemic treatment likely to substantially affect inflammatory cytokine concentrations (e.g., systemic corticosteroids or immunomodulatory agents)
* Essential clinical data or smoking-status classification unavailable
* Biological samples insufficient, unsuitable for analysis, or failing predefined laboratory quality-control criteria

Where it's running

• The British University in Egypt
  Cairo, Egypt Recruiting

Study contacts

• Study coordinator: Dalia Ghalwash, professor
• Email: dalia.ghalwash@bue.edu.edu.eg
• Phone: +20 10 05120159

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.