The Senstivity and Specificity of Using Salivary miRNAs in Detection of Malignant Transformation of Oral Lesions.

Study Overview
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Brief Summary
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Due to cancer is a leading cause of death world wide , we will coduct the study to evaluate the diagnostic accuracy of using salivary miRNAs (412,512) from the salivary extracellular vesicles (index test) in detection of the malignant transformation of the premalignant lesions using the qualitative real time polymerase chain reaction (qRT-PCR) analysis in comparison to taking biopsy .

Detailed Description
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our study is a case control study,we will coduct our study to evaluate specificity and sensitivity of using salivary extracellular vesicles miRNAs (412,512) in detection of malignant transformation in potientially malignant oral lesions by using qRT-PCR analysis ,participants will be selected and arranged in 3 groups the control group, potentially malignant group and malignant group ,the salivary samples from the participants will be collected and then microRNA extraction steps will be done through the laboratory steps ,that include extracellular vesicles isolation, PCR Analysis for miRNA-412 and miRNA-512 expression ,also the histopathologic diagnosis and examination of all specimens were confirmed by pathologist.

Official Title
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The Senstivity and Specificity of Using Salivary Extracellular Vesicles as Non -Invasive Source of miRNAs (412,512) in Detection of Malignant Transformation of Potientially Malignant Oral Lesions.

Conditions
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Oral Premalignant Lesions

Intervention / Treatment
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* Diagnostic Test: using salivary miRNA (412,512)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinically evident lesions as morphologically altered tissue noted at conventional visual tactile examination Clinically evident suspicious lesions which are morphologically altered tissue noted at comprehensive visual ductile examination ( CVTE) with a definitive diagnosis of a potentially malignant disorders (PMD) or even a malignant disorder to be a distinct possibly. Healthy subjects presenting no clinically detectable oral lesions matched for age, gender, and risk factors will recruited as controls. Exclusion Criteria: .<18 years of age. pregnant or breast feeding. .psychiatrically or mentally unstable.

Ages Eligible for Study
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Minimum Age: 35 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 |
| --- | --- |
| normal group<br>participants with out any systemic medical problemes or oral lesions. we will only take saliva sample. | Diagnostic Test: using salivary miRNA (412,512)<br>* quantitative real time polymerase chain reaction to detect the salivary miRNAs 412,512) to indicate the malignant transformation in potientially malignant oral lesions.<br>* Other names: biopsy sample for potientially maliganat and malignant group;|
| potientially malignant group<br>participants with suspicious oral lesions without any medical diseases. we will take saliva sample and take a biopsy sample . | Diagnostic Test: using salivary miRNA (412,512)<br>* quantitative real time polymerase chain reaction to detect the salivary miRNAs 412,512) to indicate the malignant transformation in potientially malignant oral lesions.<br>* Other names: biopsy sample for potientially maliganat and malignant group;|
| malignant group<br>participants with already diagnosed oral malignant lesions without receiving any treatment yett | Diagnostic Test: using salivary miRNA (412,512)<br>* quantitative real time polymerase chain reaction to detect the salivary miRNAs 412,512) to indicate the malignant transformation in potientially malignant oral lesions.<br>* Other names: biopsy sample for potientially maliganat and malignant group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the sensitivity and specificity of salivary miRNAs (412,512) to detect the malignant transformation of oral potentially malignant lesions | measuring the sensitivity and specificity of using the salivary miRNAs(412,512)to detect the malignant transformation in potentially malignant lesions | 2 years |