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

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.

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 .

Study Overview

• Status: Completed
• Conditions: Oral Premalignant Lesions
• Intervention / Treatment: Diagnostic test: using salivary miRNA (412,512)

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 Type: Observational
• Enrollment (Actual): 18

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

• Group of normal control subjects: 18 Healthy subjects presenting no clinically detectable oral lesions matched for age, gender, and risk factors .Group of subjects with potentially malignant lesions: 18 patient with innocuous lesions.
• Group of subjects with malignant lesions:18 patient with suspicious lesions

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
normal group; participants with out any systemic medical problemes or oral lesions. we will only take saliva sample.	Diagnostic test: 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.; Other Names: biopsy sample for potientially maliganat and malignant group
potientially malignant group; 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); quantitative real time polymerase chain reaction to detect the salivary miRNAs 412,512) to indicate the malignant transformation in potientially malignant oral lesions.; Other Names: biopsy sample for potientially maliganat and malignant group
malignant group; participants with already diagnosed oral malignant lesions without receiving any treatment yett	Diagnostic test: 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.; Other Names: biopsy sample for potientially maliganat and malignant group

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Ghareeb, Assistant lecturer

Study record dates

Study Major Dates

• Study Start (Actual): June 5, 2019
• Primary Completion (Actual): January 7, 2020
• Study Completion (Actual): August 7, 2020

Study Registration Dates

• First Submitted: May 29, 2021
• First Submitted That Met QC Criteria: May 29, 2021
• First Posted (Actual): June 4, 2021

Study Record Updates

• Last Update Posted (Actual): June 9, 2021
• Last Update Submitted That Met QC Criteria: June 5, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Precancerous Conditions
• Other Study ID Numbers: 19 September,2018 ,Version 2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided