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OpenTrials
Completed

NCT Number: NCT06219330

Cathelicidin LL-37 Relation to Potentially Malignant Lesions

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.

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Key information

Age range

30 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Sandy hassan shaaban

Cairo, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

Primary outcomes

  1. Cathelicidin LL-37 level in salivary samples from all participants mesured using ELISA

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Fayoum University

Other

Collaborators

  • Cairo University

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jan 23, 2024
Registry last updated
Jan 23, 2024

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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