Cathelicidin LL-37 Relation to Potentially Malignant Lesions

Completed

• Conditions: Oral Potentially Malignant Lesions

• Registration Number: NCT06219330
• Lead Sponsor: Fayoum University

Brief Summary

LL-37 appears to have a potential role in potentially malignant lesions (OLP \& leukoplakia). The remarkable diagnostic accuracy of salivary LL-37 in differentiating potentially malignant lesion and healthy control could confirm its utilization as an innovative marker to early diagnose potentially malignant lesions. Salivary LL-37 being non-invasive accurate marker could be as a chair-side diagnostic method that detect potentially malignant lesions.

Detailed Description

Aim: The recognition of practical early diagnostic biomarkers is a cornerstone of improved prevention and treatment of cancer thus the current study estimated salivary level of Cathelicidin LL-37 in patients suffering from potentially malignant lesions and control subjects to corroborate Cathelicidin LL-37 as a diagnostic marker for early detection of potentially malignant diseases and revealing its possible role in carcinogenesis.

Methodology: 45 systemically healthy individuals were subdivided into three groups: Group I: 15 Healthy participants without any oral lesions. Group II: 15 Patients having atrophic/erosive oral lichen planus (OLP). Group III: 15 Patients having oral leukoplakia.. Enzyme linked immune-sorbent assay (ELIZA) kit was used to evaluate the level of LL-37 in whole unstimulated salivary samples collected from all participants. To reveal AUC, sensitivity, specificity, and diagnostic accuracy of LL-37 receiver operating curve (ROC) analysis was done.

Study Timeline

• Study Start: 2023-07-01
• Primary Completion: 2023-10-30
• Study Completion: 2023-11-15
• Status Verified: 2024-01
• Study First Submitted: 2024-01-02
• Study First Submitted QC: 2024-01-12
• Last Update Submitted: 2024-01-12
• Study First Posted: 2024-01-23
• Last Update Posted: 2024-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

• Both genders with age range 30 - 70 years.
• Patients agreed to sign a written consent after understanding the nature of the study.
• Clinically diagnosed and histologically confirmed as having oral potentially malignant lesions mainly atrophic/erosive oral lichen planus and oral leukoplakia.

Exclusion Criteria

• Systemic diseases as well as pregnant or lactating females.
• Patients currently taking corticosteroids, immunosuppressives drugs, contraceptive pills, or antibiotics.
• Patients are diagnosed with any other oral lesions other than oral lichen planus and oral leukoplakia.
• Vulnerable subjects as prisoners, or mentally disabled.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cathelicidin LL-37 level in salivary samples from all participants mesured using ELISA	level of LL-37 is measured after the completion of all sample collection carried at the 1 day of enrollement of subjects in the investigation after diagnosis confirmation	ELISA is used to estimate Cathelicidin LL-37 levels in saliva samples from patients with OPMD compared to healthy subjects

Trial Locations

Locations (1)

Sandy hassan shaaban; 🇪🇬 Cairo, Egypt