Clinical trial NCT06219330: Cathelicidin LL-37 Relation to Potentially Malignant Lesions
Official title: "Salivary Levels of Cathelicidin LL-37 in Patients With Oral Potentially Malignant Lesions, A Case Control Study"
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Oral Potentially Malignant Lesions
Keywords: Oral potentially malignant lesions, Cathelicidin LL-37
Lead sponsor: Fayoum University
Sponsor class: OTHER
Collaborators: name: Cairo University
First posted: 2024-01-23
Enrollment: 45
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: A total number of 45 systemically healthy participants were included in this study that were divided equally into 3 groups: Group I: 15 Healthy participants without any oral lesions. Group II: 15 Patients having atrophic/ erosive oral lichen planus. Group III: 15 Patients having oral leukoplakia.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Cathelicidin LL-37 level in salivary samples from all participants mesured using ELISA
timeFrame: 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
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Sandy hassan shaaban
Study officials:
References: