Cathelicidin LL-37 Relation to Potentially Malignant Lesions

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06219330

Enrollment

Registered

2024-01-23

Start date

2023-07-01

Completion date

2023-11-15

Last updated

2024-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oral Potentially Malignant Lesions

Keywords

Oral potentially malignant lesions, Cathelicidin LL-37

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

30 Years to 70 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

Egypt

Outcome results