Salivary IL-8 and Serum IL-6 as Biomarkers for Oral Potentially Malignant Disorders in Smokers and Never-Smokers
NCT07915570, Recruiting, British University In Egypt
Trial 9
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Salivary IL-8 and Serum IL-6 as Biomarkers for Oral Potentially Malignant Disorders in Smokers and Never-Smokers | ClinicalTrials.gov |
| NCT number | NCT07915570 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Enrollment | 250 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | British University In Egypt | ClinicalTrials.gov |
| Conditions | Oral Potentially Malignant Disorders, Oral Lichen Planus, Oral Leukoplakia, Oral Squamous Cell Carcinoma, Smoking | ClinicalTrials.gov |
| Interventions | Salivary IL-8 and Serum IL-6 Measurement | ClinicalTrials.gov |
| First posted | 2026-11-04 | ClinicalTrials.gov |
| Last updated | 2026-11-04 | ClinicalTrials.gov |
Registered outcomes 8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Salivary IL-8 Concentration | At enrollment (single visit, before any definitive lesion treatment) | Salivary interleukin-8 (IL-8) concentration, measured using an enzyme-linked immunosorbent assay (ELISA) and expressed in pg/mL. Concentrations are compared between healthy controls and participants with oral potentially malignant disorders (OPMDs), with analyses stratified by smoking status where applicable. | ClinicalTrials.gov |
| Primary | Serum IL-6 Concentration | At enrollment (single visit, before any definitive lesion treatment) | Serum interleukin-6 (IL-6) concentration, measured using an ELISA and expressed in pg/mL. Concentrations are compared between healthy controls and participants with OPMDs, with analyses stratified by smoking status where applicable. | ClinicalTrials.gov |
| Secondary | Diagnostic Discrimination (AUC) of Salivary IL-8, Serum IL-6 and Their Combination for OPMD Versus Healthy Controls | At enrollment (single visit) | Area under the receiver operating characteristic curve (AUC) with 95% bootstrap confidence intervals for IL-8 alone, IL-6 alone and both combined, overall and stratified by smoking status (stratified analyses descriptive). | ClinicalTrials.gov |
| Secondary | Sensitivity and Specificity of Salivary IL-8 and Serum IL-6 for OPMD Versus Healthy Controls | At enrollment (single visit) | Sensitivity and specificity (%) of each biomarker and their combination at cut-off values selected using Youden's index. | ClinicalTrials.gov |
| Secondary | Salivary IL-8 and Serum IL-6 Concentrations by OPMD Subtype and Dysplasia Status | At enrollment (single visit) | Biomarker concentrations (pg/mL) compared between oral lichen planus and oral leukoplakia, and between OPMD lesions with and without histopathological epithelial dysplasia. | ClinicalTrials.gov |
| Secondary | Correlation Between Salivary IL-8 and Serum IL-6 Concentrations | At enrollment (single visit) | The correlation between salivary IL-8 concentration (pg/mL) and serum IL-6 concentration (pg/mL), both measured using ELISA, is assessed using Pearson's correlation coefficient (r), with Spearman's rank correlation coefficient (ρ) used as a complementary measure. | ClinicalTrials.gov |
| Other | Exploratory: Discrimination of OSCC Versus Current-Smoking OPMD by Salivary IL-8 and Serum IL-6 | At enrollment (single visit) | AUC with 95% bootstrap confidence intervals for IL-8, IL-6 and their combination in discriminating current-smoking patients with oral squamous cell carcinoma from current-smoking patients with OPMDs. | ClinicalTrials.gov |
| Other | Exploratory: Cross-Validated Performance of Biomarker-Based Prediction Models for OPMD | At enrollment (single visit) | AUC and Brier score (with sensitivity, specificity and accuracy where reported) of logistic-regression models evaluated with repeated stratified five-fold cross-validation (20 repetitions), comparing four predictor sets: IL-8; IL-8 + IL-6; both biomarkers + smoking status; and these plus demographic and periodontal variables. Internal validation only. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)