NCT06219330

Completed

Cathelicidin LL-37 Relation to Potentially Malignant Lesions

Fayoum University Source

Compare

Other study identifiers

Sponsor study identifier

63723

Study Type

observational

Actual enrollment (reported)

45

Locations

1 country

Sites

1

Timeline

Study Start

July 1, 2023

Actual (reported)

Primary Completion

October 30, 2023

Actual (reported)

Study Completion

November 15, 2023

Actual (reported)

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 45 participants
Study completion date: November 15, 2023
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
July 1, 2023
Actual (reported)
Primary Completion
October 30, 2023
Actual (reported)
Study Completion
November 15, 2023
Actual (reported)
First Submitted
January 2, 2024
Actual (reported)
First Posted
January 23, 2024
Actual (reported)

Last Updated: January 23, 2024
Status Verified: January 2024
Last Update Submitted: January 12, 2024

Conditions

Oral Potentially Malignant Lesions

Keywords

Oral potentially malignant lesions, Cathelicidin LL-37

Outcome Measures

Primary Outcomes (1)

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

Study Arms (3)

Group I (control group)

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

Group III:

15 Patients having oral leukoplakia

Eligibility Criteria

Age30 Years - 70 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodProbability 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.

You may qualify if:

Both genders with age range 30 - 70 years.

Sponsors & Collaborators

Fayoum University
Otherlead
Cairo University
Othercollaborator

Study Sites (1)

Sandy hassan shaaban

Cairo, Egypt

Enrollment

45 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: CASE CONTROL
Time Perspective: RETROSPECTIVE
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Associate professor oral medicine & periodontology departement

Study Record Dates

First Submitted

January 2, 2024

First Posted

January 23, 2024

Study Start

July 1, 2023

Actual (reported)

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.

You may not qualify if:

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.

Contact the study team to confirm eligibility.

Primary Completion

October 30, 2023

Actual (reported)

Study Completion

November 15, 2023

Actual (reported)

Last Updated

January 23, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing: Will not share

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT06219330
Data provider: ClinicalTrials.gov
Source updated: 2024-01-23
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:26:48 UTC

Locations

EG(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (3)

Group I (control group)

Group II:

Group III:

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations