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

Completed

• Conditions: Oral Premalignant Lesions

• Registration Number: NCT04913545
• Lead Sponsor: Cairo University

Brief Summary

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

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.

Study Timeline

• Study Start: 2019-06-05
• Primary Completion: 2020-01-07
• Study Completion: 2020-08-07
• Study First Submitted: 2021-05-29
• Study First Submitted QC: 2021-05-29
• Status Verified: 2021-06
• Study First Posted: 2021-06-04
• Last Update Submitted: 2021-06-05
• Last Update Posted: 2021-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
the sensitivity and specificity of salivary miRNAs (412,512) to detect the malignant transformation of oral potentially malignant lesions	2 years	measuring the sensitivity and specificity of using the salivary miRNAs(412,512)to detect the malignant transformation in potentially malignant lesions

Trial Locations

Locations (1)

Dentistry; 🇪🇬 Cairo, Egypt