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

NCT05730855 | Completed DMC

• 1 other identifier: 1152014
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Potentially Malignant Lesions; Oral Lichen Planus; Leukoplakia, Oral

Keywords

lncRNA DQ786243; saliva; oral potentially malignant lesions; miRNA146a

Outcome Measures

Primary Outcomes (1)

• salivary expression of lncDQ786243 in OLP, Leukoplakia, control

  2 months

Secondary Outcomes (1)

• salivary expression of miRNA146a in OLP, Leukoplakia, control

  2 months

Study Arms (3)

Oral Lichen Planus

Diagnostic Test: Real-time Polymerase Chain Reaction technique

Leukoplakia

Diagnostic Test: Real-time Polymerase Chain Reaction technique

Healthy control

Diagnostic Test: Real-time Polymerase Chain Reaction technique

Interventions

Real-time Polymerase Chain Reaction technique DIAGNOSTIC_TEST

Real-time Polymerase Chain Reaction technique

Healthy control; Leukoplakia; Oral Lichen Planus

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Egyptian Population

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fayoum University: lead

Study Sites (1)

Fayoum University

Al Fayyum, Egypt

Location

MeSH Terms

Conditions

Lichen Planus, Oral; Leukoplakia, Oral

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Lichen Planus; Lichenoid Eruptions; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Mouth Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Leukoplakia; Precancerous Conditions; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: February 7, 2023
• First Posted: February 16, 2023
• Study Start: November 1, 2022
• Primary Completion: December 24, 2022
• Study Completion: January 23, 2023
• Last Updated: September 13, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

EG (1)