Potentially Malignant LesionsNCT05730855
Diagnostic Accuracy of lncRNA DQ786243 and miRNA146a in Saliva of Oral Potentially Malignant Lesions
An observational study of Potentially Malignant Lesions and Oral Lichen Planus, run by Fayoum University at 1 site in Egypt.
Trial summary
The aim of this study is to evaluate salivary expression of lncRNA DQ786243 as a potential marker for diagnosis of oral potentially malignant lesions compared to normal controls and its effect on salivary expression of miRNA146a. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Potentially Malignant Lesions, Oral Lichen Planus, Leukoplakia, Oral
- What is being tested?
- Real-time Polymerase Chain Reaction technique
- How many people
- 45 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2022to 23 Jan 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Egyptian Population
Who may be able to join
- participants will be divided into 3 groups:
- Group I: patients suffering from oral lichen planus Group II: patients suffering from leukoplakia Group III: healthy subjects who are systemically free, non-smokers, and not suffering from any oral mucosal lesions.
Who cannot join
- Subjects taking any drugs inducing any changes that could affect the salivary flow.
- Pregnant females.
- Subjects have any allergies, infectious diseases or active dental abscesses during one month before saliva sampling.
- Patients receiving any drugs related to the oral lesions in the past 6 month prior to sample collection.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to evaluate salivary expression of lncRNA DQ786243 as a potential marker for diagnosis of oral potentially malignant lesions compared to normal controls and its effect on salivary expression of miRNA146a.
- Being tested
- Real-time Polymerase Chain Reaction technique
- Keywords
- lncRNA DQ786243, saliva, oral potentially malignant lesions, miRNA146a
- Medical subject headings
- Lichen Planus, Oral, Leukoplakia, Oral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Real-time Polymerase Chain Reaction techniqueDiagnostic test
Real-time Polymerase Chain Reaction technique
| Study group | Role | What they receive |
|---|---|---|
| Oral Lichen Planus | Not described Receives: Diagnostic Test: Real-time Polymerase Chain Reaction technique | |
| Leukoplakia | Not described Receives: Diagnostic Test: Real-time Polymerase Chain Reaction technique | |
| Healthy control | Not described Receives: Diagnostic Test: Real-time Polymerase Chain Reaction technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
salivary expression of lncDQ786243 in OLP, Leukoplakia, control
Measured: 2 months
Secondary outcomes (1)
salivary expression of miRNA146a in OLP, Leukoplakia, control
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2023
- Study start1 Nov 2022
- Primary completion24 Dec 2022
- Study completion23 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Other
- Time perspective
- Prospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fayoum University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Salsabeel, Fayoum University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05730855
- Sponsor's protocol ID
- 1152014
- Status last verified
- Sep 2023
- First submitted
- 7 Feb 2023
- Last updated
- 13 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Afifi S, Ibrahim S, Kotb AA, ElRefai S, Hafed L, Shaker O, Baz S, Shalaby R. Long noncoding RNA DQ786243 and miRNA146a as potential salivary biomarkers for selected oral potentially malignant disorders: a diagnostic accuracy study. Oral Surg Oral Med Oral Pathol Oral Radiol. 2026 Jan;141(1):96-105. doi: 10.1016/j.oooo.2025.08.013. Epub 2025 Aug 27.
PubMed 40973523
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Accuracy of lncRNA DQ786243 and miRNA146a in Saliva of Oral Potentially Malignant Lesions
- ClinicalTrials.gov ID
- NCT05730855
- Acronym / sponsor ID
- 1152014
- Keywords
- lncRNA DQ786243, saliva, oral potentially malignant lesions, miRNA146a
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Fayoum UniversityUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 24 Dec 2022 (actual)
- Study completion
- 23 Jan 2023 (actual)
- First posted
- 16 Feb 2023 (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.
The aim of this study is to evaluate salivary expression of lncRNA DQ786243 as a potential marker for diagnosis of oral potentially malignant lesions compared to normal controls and its effect on salivary expression of miRNA146a.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Oral Lichen Planus | – | Diagnostic Test: Real-time Polymerase Chain Reaction technique |
| Leukoplakia | – | Diagnostic Test: Real-time Polymerase Chain Reaction technique |
| Healthy control | – | Diagnostic Test: Real-time Polymerase Chain Reaction technique |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Egyptian Population
Key inclusion criteria (2 listed)
- participants will be divided into 3 groups:
- Group I: patients suffering from oral lichen planus Group II: patients suffering from leukoplakia Group III: healthy subjects who are systemically free, non-smokers, and not suffering from any oral mucosal lesions.
Key exclusion criteria (4 listed)
- Subjects taking any drugs inducing any changes that could affect the salivary flow.
- Pregnant females.
- Subjects have any allergies, infectious diseases or active dental abscesses during one month before saliva sampling.
- Patients receiving any drugs related to the oral lesions in the past 6 month prior to sample collection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Real-time Polymerase Chain Reaction techniqueReal-time Polymerase Chain Reaction technique | Diagnostic test | Healthy control, Leukoplakia, Oral Lichen Planus |
Primary outcome
salivary expression of lncDQ786243 in OLP, Leukoplakia, control
Time frame: 2 months
1 secondary outcome
salivary expression of miRNA146a in OLP, Leukoplakia, control
Time frame: 2 months
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 13 Sep 2023.
- Derived from this study: PubMed 40973523Afifi S, Ibrahim S, Kotb AA, ElRefai S, Hafed L, Shaker O, Baz S, Shalaby R. Long noncoding RNA DQ786243 and miRNA146a as potential salivary biomarkers for selected oral potentially malignant disorders: a diagnostic accuracy study. Oral Surg Oral Med Oral Pathol Oral Radiol. 2026 Jan;141(1):96-105. doi: 10.1016/j.oooo.2025.08.013. Epub 2025 Aug 27.
- Individual participant dataSharing planned: Yes
Related trials for Potentially Malignant Lesions
RecruitingObservational study
Defining the Natural History of Squamous Cell Carcinoma in Fanconi Anemia
Fanconi Anemia, Inherited Bone Marrow Failure Syndrome
Active, not recruitingEarly Phase 1
Multimodal Imaging for Surveillance in Patients With Oral Potentially Malignant Disorders
Dysplasia, Lip and Oral Cavity Carcinoma
RecruitingObservational study
Evaluation of Cell Changes in Blood and Tissue in Cancers of the Lung, Esophagus and Lung Lining
Thoracic Cancers, Malignant Pleural Mesotheliomas NOS
Not yet recruiting
Feasibility and Validation of an Automated AI-Enabled Deep Ultraviolet (DUV) Cytology Platform for Point-of-Care Oral Cancer Triage
Oral Potentially Malignant Lesions, Oral Potentially Malignant Disorders
Enrolling by invitation
The Importance of Mucosal Screening in the Prevention of Oral Cancer.
OPMD, Oral Cancer , Oral Squamous Cell Carcinoma, Oral Cavity Cancer
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 Potentially Malignant Lesions and Oral Lichen Planus, 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 2 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 13 Sep 2023. 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?
salivary expression of lncDQ786243 in OLP, Leukoplakia, control (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05730855, which also lists 1 linked publication.
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 13 Sep 2023.