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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

18 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-06-05

Study Completion Date

2020-08-07

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 .

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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.

Conditions

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Oral Premalignant Lesions

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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normal group

participants with out any systemic medical problemes or oral lesions. we will only take saliva sample.

using salivary miRNA (412,512)

Intervention Type DIAGNOSTIC_TEST

quantitative real time polymerase chain reaction to detect the salivary miRNAs 412,512) to indicate the malignant transformation in potientially malignant oral lesions.

potientially malignant group

participants with suspicious oral lesions without any medical diseases. we will take saliva sample and take a biopsy sample .

using salivary miRNA (412,512)

Intervention Type DIAGNOSTIC_TEST

quantitative real time polymerase chain reaction to detect the salivary miRNAs 412,512) to indicate the malignant transformation in potientially malignant oral lesions.

malignant group

participants with already diagnosed oral malignant lesions without receiving any treatment yett

using salivary miRNA (412,512)

Intervention Type DIAGNOSTIC_TEST

quantitative real time polymerase chain reaction to detect the salivary miRNAs 412,512) to indicate the malignant transformation in potientially malignant oral lesions.

Interventions

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using salivary miRNA (412,512)

quantitative real time polymerase chain reaction to detect the salivary miRNAs 412,512) to indicate the malignant transformation in potientially malignant oral lesions.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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biopsy sample for potientially maliganat and malignant group

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.