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

• Sponsor: Fayoum University (Other)
• Overall Status: Completed
• CT.gov ID: NCT05730855
• Collaborator: (none)
• Enrollment: 45
• Location: 1
• Actual Duration (Months): 2.7
• Patients Per Site Per Month: 16.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Potentially Malignant Lesions, Oral Lichen Planus, Leukoplakia	Diagnostic Test: Real-time Polymerase Chain Reaction technique

Study Design

• Study Type: Observational
• Actual Enrollment: 45 participants
• Observational Model: Other
• Time Perspective: Prospective
• Official Title: Diagnostic Accuracy of lncRNA DQ786243 and miRNA146a in Saliva of Oral Potentially Malignant Lesions
• Actual Study Start Date: Nov 1, 2022
• Actual Primary Completion Date: Dec 24, 2022
• Actual Study Completion Date: Jan 23, 2023

Arms and Interventions

Arm	Intervention/Treatment
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
Healthy control	Diagnostic Test: Real-time Polymerase Chain Reaction technique; Real-time Polymerase Chain Reaction technique

Outcome Measures

Primary Outcome Measures

1. salivary expression of lncDQ786243 in OLP, Leukoplakia, control [2 months]

Secondary Outcome Measures

1. salivary expression of miRNA146a in OLP, Leukoplakia, control [2 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fayoum University	Fayoum		Egypt

Sponsors and Collaborators

• Fayoum University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Salsabeel, Lecturer, Fayoum University
• ClinicalTrials.gov Identifier: NCT05730855
• Other Study ID Numbers: 1152014
• First Posted: Feb 16, 2023
• Last Update Posted: Feb 16, 2023
• Last Verified: Feb 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Salsabeel, Lecturer, Fayoum University: lncRNA DQ786243; saliva; oral potentially malignant lesions; miRNA146a
• Additional relevant MeSH terms: Leukoplakia; Lichen Planus, Oral; Lichen Planus

Study Results

No Results Posted as of Feb 16, 2023