Oral Potentially Malignant LesionsNCT06219330
Cathelicidin LL-37 Relation to Potentially Malignant Lesions
An observational study of Oral Potentially Malignant Lesions, run by Fayoum University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 30 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Oral Potentially Malignant Lesions
- Type of treatment
- Pill or oral medicine
- How many people
- 45 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2023to 15 Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: "Salivary Levels of Cathelicidin LL-37 in Patients With Oral Potentially Malignant Lesions, A Case Control Study"
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.
Read the 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.
- Conditions
- Oral Potentially Malignant Lesions
- Keywords
- Oral potentially malignant lesions, Cathelicidin LL-37
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2024
- Study start1 Jul 2023
- Primary completion30 Oct 2023
- Study completion15 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral Potentially Malignant LesionsStudies of the same condition, open and under way.
- More trials run by Fayoum UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fayoum University
- Sponsor type
- University, hospital or other
- Collaborators
- Cairo University
- Responsible party
- Principal investigator, Sandy Hassan, Fayoum University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06219330
- Sponsor's protocol ID
- 63723
- Status last verified
- Jan 2024
- First submitted
- 2 Jan 2024
- Last updated
- 23 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Salivary Levels of Cathelicidin LL-37 in Patients With Oral Potentially Malignant Lesions, A Case Control Study"
- ClinicalTrials.gov ID
- NCT06219330
- Acronym / sponsor ID
- 63723
- Conditions
- Oral Potentially Malignant Lesions
- Keywords
- Oral potentially malignant lesions, Cathelicidin LL-37
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Fayoum UniversityUniversity, hospital or other
- Collaborators
- Cairo University
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 30 Oct 2023 (actual)
- Study completion
- 15 Nov 2023 (actual)
- First posted
- 23 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oral Potentially Malignant Lesions, run by Fayoum University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2024.