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

Oral Premalignant Lesions Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04913545
• Other study ID #: 19 September,2018 ,Version 2
• Status: Completed
• Start date: June 5, 2019
• Est. completion date: August 7, 2020

Study information

• Verified date: June 2021
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 .

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: August 7, 2020
• Est. primary completion date: January 7, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Oral Premalignant Lesions
• Precancerous Conditions

Intervention

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.

Locations

Country	Name	City	State
Egypt	Dentistry	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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