Diagnostic Accuracy of lncRNA DQ786243 and miRNA146a in Saliva of Oral Potentially Malignant Lesions

September 8, 2023 updated by: Salsabeel, Fayoum University
The aim of this study is to evaluate salivary expression of lncRNA DQ786243 as a potential marker for diagnosis of oral potentially malignant lesions compared to normal controls and its effect on salivary expression of miRNA146a.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

45

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Fayoum, Egypt
        • Fayoum university

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Egyptian Population

Description

Inclusion Criteria:

  • participants will be divided into 3 groups:

Group I: patients suffering from oral lichen planus Group II: patients suffering from leukoplakia Group III: healthy subjects who are systemically free, non-smokers, and not suffering from any oral mucosal lesions.

Exclusion Criteria:

  • Subjects taking any drugs inducing any changes that could affect the salivary flow.
  • Pregnant females.
  • Subjects have any allergies, infectious diseases or active dental abscesses during one month before saliva sampling.
  • Patients receiving any drugs related to the oral lesions in the past 6 month prior to sample collection.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Healthy control
Diagnostic test: Real-time Polymerase Chain Reaction technique
Real-time Polymerase Chain Reaction technique
Oral Lichen Planus
Diagnostic test: Real-time Polymerase Chain Reaction technique
Real-time Polymerase Chain Reaction technique
Leukoplakia
Diagnostic test: Real-time Polymerase Chain Reaction technique
Real-time Polymerase Chain Reaction technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
salivary expression of lncDQ786243 in OLP, Leukoplakia, control
Time Frame: 2 months
2 months

Secondary Outcome Measures

Outcome Measure
Time Frame
salivary expression of miRNA146a in OLP, Leukoplakia, control
Time Frame: 2 months
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fayoum University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2022

Primary Completion (Actual)

December 24, 2022

Study Completion (Actual)

January 23, 2023

Study Registration Dates

First Submitted

February 7, 2023

First Submitted That Met QC Criteria

February 7, 2023

First Posted (Actual)

February 16, 2023

Study Record Updates

Last Update Posted (Actual)

September 13, 2023

Last Update Submitted That Met QC Criteria

September 8, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1152014

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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