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NCT05821179 Clinical Trial

Salivary LINC00657 as a Diagnostic Biomarker for Oral Squamous Cell Carcinoma

Oral Squamous Cell Carcinoma Clinical Trial

Official title:
Salivary LINC00657 as a Diagnostic Biomarker for Oral Squamous Cell Carcinoma

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05821179
Other study ID # M1
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2022
Est. completion date February 25, 2023

Study information
Verified date April 2023
Source Fayoum University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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

Recruitment information / eligibility
Status Completed
Enrollment 36
Est. completion date February 25, 2023
Est. primary completion date January 1, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 70 Years
Eligibility Inclusion Criteria: - group I : oral squamous cell carcinoma lesions (OSCC) - group II: oral lichen planus lesions (OLP) - group III: systemically healthy volunteers Exclusion Criteria: - oral lesions other than OSCC / OLP in group I and II - any oral lesion in group III - pregnant females

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Egypt faculty of dentistry, Fayoum university Fayoum

Sponsors (1)
Lead Sponsor Collaborator
Fayoum University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary LINC00657 level in salivary samples from all participants measured using PCR quantitative real-time PCR is used to detect LINC00657 levels in saliva samples from patients with OSCC and OPMD compared to healthy subjects 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
Secondary miR-106a level in salivary samples from the included subjects evaluated by PCR quantitative real-time PCR is used to detect miR106a levels in saliva samples from patients with OSCC and OPMD compared to healthy subjects 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
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