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

NCT04913545 | Completed

• 1 other identifier: 19 September,2018 ,Version 2
• Study Type: observational
• Target: 18
• Locations: 1 country
• Sites: 1

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 .

Conditions

Oral Premalignant Lesions

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

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)

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)

malignant group

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

Diagnostic Test: using salivary miRNA (412,512)

Interventions

using salivary miRNA (412,512) DIAGNOSTIC_TEST

quantitative real time polymerase chain reaction to detect the salivary miRNAs 412,512) to indicate the malignant transformation in potientially malignant oral lesions.

Also known as: biopsy sample for potientially maliganat and malignant group

malignant group; normal group; potientially malignant group

Eligibility Criteria

• Age: 35 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• \<18 years of age.
• pregnant or breast feeding. .psychiatrically or mentally unstable.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Dentistry

Cairo, Egypt

Location

Study Officials

• Ghareeb

  Assistant lecturer

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecturer in MSA university

Study Record Dates

• First Submitted: May 29, 2021
• First Posted: June 4, 2021
• Study Start: June 5, 2019
• Primary Completion: January 7, 2020
• Study Completion: August 7, 2020
• Last Updated: June 9, 2021

Record last verified: 2021-06

Locations

EG (1)