Salivary LINC00657 as a Diagnostic Biomarker for Oral Squamous Cell Carcinoma

Study Overview
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Brief Summary
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This study was designed to verify the role of salivary LINC00657 as a diagnostic marker in oral squamous cell carcinoma (OSCC) patients as compared to oral lichen planus (OLP) (as an example of oral potentially malignant lesions) and normal individuals, and to show its relation to miR-106a. A total of 36 participants were included.

Detailed Description
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This study was designed to verify the role of salivary LINC00657 as a diagnostic marker in oral squamous cell carcinoma (OSCC) patients as compared to oral lichen planus (OLP) (as an example of oral potentially malignant lesions) and normal individuals, and to show its relation to miR-106a. A total of 36 participants were included, subdivided into 3 groups: Group I: 12 patients diagnosed with OSCC. Group II: 12 patients diagnosed with OLP. Group III: 12 systemically free individuals with no oral mucosal lesions. statistical analysis and ROC analysis were performed

Official Title
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Salivary LINC00657 as a Diagnostic Biomarker for Oral Squamous Cell Carcinoma

Conditions
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Oral Squamous Cell Carcinoma

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: group I : oral squamous cell carcinoma lesions (OSCC) group II: oral lichen planus lesions (OLP) group III: systemically healthy volunteers Exclusion Criteria: oral lesions other than OSCC / OLP in group I and II any oral lesion in group III pregnant females

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group I<br>12 patients diagnosed with OSCC. | |
| Group II<br>12 patients diagnosed with OLP. | |
| Group III<br>12 systemically free individuals with no oral mucosal lesions. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LINC00657 level in salivary samples from all participants measured using PCR | quantitative real-time PCR is used to detect LINC00657 levels in saliva samples from patients with OSCC and OPMD compared to healthy subjects | level of miR-106a is measured after the completion of all salivary sample collection carried at the 1 day of enrollment of subjects in the investigation after diagnosis confirmation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| miR-106a level in salivary samples from the included subjects evaluated by PCR | quantitative real-time PCR is used to detect miR106a levels in saliva samples from patients with OSCC and OPMD compared to healthy subjects | level of miR-106a is measured after the completion of all salivary sample collection carried at the 1 day of enrollment of subjects in the investigation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oral squamous cell carcinoma, oral potentially malignant disorders, saliva, LINC00657, miR-106a.