Cathelicidin LL-37 Relation to Potentially Malignant Lesions

Oral Potentially Malignant Lesions Clinical Trial

Official title:

"Salivary Levels of Cathelicidin LL-37 in Patients With Oral Potentially Malignant Lesions, A Case Control Study"

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06219330
• Other study ID #: 63723
• Status: Completed
• Start date: July 1, 2023
• Est. completion date: November 15, 2023

Study information

• Verified date: January 2024
• Source: Fayoum University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: November 15, 2023
• Est. primary completion date: October 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Oral Potentially Malignant Lesions

Locations

Country	Name	City	State
Egypt	Sandy hassan shaaban	Cairo

Sponsors (2)

Lead Sponsor	Collaborator
Fayoum University	Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cathelicidin LL-37 level in salivary samples from all participants mesured using ELISA	ELISA is used to estimate Cathelicidin LL-37 levels in saliva samples from patients with OPMD compared to healthy subjects	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