Salivary LINC00657 as a Diagnostic Biomarker for Oral Squamous Cell Carcinoma

Completed

• Conditions: Oral Squamous Cell Carcinoma

• Registration Number: NCT05821179
• Lead Sponsor: Fayoum University

Brief Summary

This study was designed to verify the role of salivary LINC00657 as a diagnostic marker in oral squamous cell carcinoma (OSCC) patients as compared to oral lichen planus (OLP) (as an example of oral potentially malignant lesions) and normal individuals, and to show its relation to miR-106a. A total of 36 participants were included.

Detailed Description

This study was designed to verify the role of salivary LINC00657 as a diagnostic marker in oral squamous cell carcinoma (OSCC) patients as compared to oral lichen planus (OLP) (as an example of oral potentially malignant lesions) and normal individuals, and to show its relation to miR-106a. A total of 36 participants were included, subdivided into 3 groups: Group I: 12 patients diagnosed with OSCC. Group II: 12 patients diagnosed with OLP. Group III: 12 systemically free individuals with no oral mucosal lesions. statistical analysis and ROC analysis were performed

Study Timeline

• Study Start: 2022-01-01
• Primary Completion: 2023-01-01
• Study Completion: 2023-02-25
• Study First Submitted: 2023-03-26
• Status Verified: 2023-04
• Study First Submitted QC: 2023-04-19
• Last Update Submitted: 2023-04-19
• Study First Posted: 2023-04-20
• Last Update Posted: 2023-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• group I : oral squamous cell carcinoma lesions (OSCC)
• group II: oral lichen planus lesions (OLP)
• group III: systemically healthy volunteers

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Exclusion Criteria

• oral lesions other than OSCC / OLP in group I and II
• any oral lesion in group III
• pregnant females

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
LINC00657 level in salivary samples from all participants measured using PCR	level of miR-106a is measured after the completion of all salivary sample collection carried at the 1 day of enrollment of subjects in the investigation after diagnosis confirmation	quantitative real-time PCR is used to detect LINC00657 levels in saliva samples from patients with OSCC and OPMD compared to healthy subjects

Secondary Outcome Measures

Name	Time	Method
miR-106a level in salivary samples from the included subjects evaluated by PCR	level of miR-106a is measured after the completion of all salivary sample collection carried at the 1 day of enrollment of subjects in the investigation	quantitative real-time PCR is used to detect miR106a levels in saliva samples from patients with OSCC and OPMD compared to healthy subjects

Trial Locations

Locations (1)

faculty of dentistry, Fayoum university; 🇪🇬 Fayoum, Egypt