Salivary LINC00657 as a Diagnostic Biomarker for Oral Squamous Cell Carcinoma

Sponsor

Fayoum University (Other)

Overall Status

Completed

CT.gov ID

NCT05821179

Collaborator

(none)

Enrollment

Location

13.8

Actual Duration (Months)

2.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Condition or Disease	Intervention/Treatment	Phase
Oral Squamous Cell Carcinoma

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 Design

Study Type:

Observational

Actual Enrollment :

36 participants

Observational Model:

Case-Control

Time Perspective:

Cross-Sectional

Official Title:

Salivary LINC00657 as a Diagnostic Biomarker for Oral Squamous Cell Carcinoma

Actual Study Start Date :

Jan 1, 2022

Actual Primary Completion Date :

Jan 1, 2023

Actual Study Completion Date :

Feb 25, 2023

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	faculty of dentistry, Fayoum university	Fayoum		Egypt

Sponsors and Collaborators

Fayoum University

Investigators

Principal Investigator: Nayroz Tarrad, as. professor, faculty of dentistry, Fayoum university

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Nayroz Tarrad, associate professor, Fayoum University

ClinicalTrials.gov Identifier:

NCT05821179

Other Study ID Numbers:

First Posted:

Apr 20, 2023

Last Update Posted:

Apr 20, 2023

Last Verified:

Apr 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Nayroz Tarrad, associate professor, Fayoum University

Oral squamous cell carcinoma, oral potentially malignant disorders, saliva, LINC00657, miR-106a.

Additional relevant MeSH terms:

Carcinoma

Carcinoma, Squamous Cell

Squamous Cell Carcinoma of Head and Neck

Study Results

No Results Posted as of Apr 20, 2023