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

Cairo University (CU)

Status: Completed

Conditions: Oral Premalignant Lesions

Treatments: Diagnostic Test: using salivary miRNA (412,512)

Study type: Observational

Funder types: Other

Identifiers

NCT04913545

19 September,2018 ,Version 2

Details and patient eligibility

About

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 .

Full description

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.

Enrollment: 18 patients

Sex: All

Ages: 35 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

18 participants in 3 patient groups

normal group

Description:

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

Treatment:

Diagnostic Test: using salivary miRNA (412,512)

potientially malignant group

Description:

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

Treatment:

Diagnostic Test: using salivary miRNA (412,512)

malignant group

Description:

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

Treatment:

Diagnostic Test: using salivary miRNA (412,512)