Clinical trial NCT04913545: The Senstivity and Specificity of Using Salivary miRNAs in Detection of Malignant Transformation of Oral Lesions.
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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Oral Premalignant Lesions
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-06-04
Enrollment: 18
Sex: ALL
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: the sensitivity and specificity of salivary miRNAs (412,512) to detect the malignant transformation of oral potentially malignant lesions
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Dentistry
Study officials:
affiliation: Assistant lecturer
name: Ghareeb
role: PRINCIPAL_INVESTIGATOR
References: