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Completed

NCT Number: NCT05821179

Salivary LINC00657 as a Diagnostic Biomarker for Oral Squamous Cell Carcinoma

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.

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Key information

Conditions

Oral Squamous Cell Carcinoma Carcinoma Carcinoma, Squamous Cell Head and Neck Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Squamous Cell Carcinoma of Head and Neck

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

faculty of dentistry, Fayoum university

Al Fayyum, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. LINC00657 level in salivary samples from all participants measured using PCR

    Time frame: 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 outcomes

  1. miR-106a level in salivary samples from the included subjects evaluated by PCR

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Fayoum University

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 20, 2023
Registry last updated
Apr 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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