Oral Lichen PlanusNCT05400057
the Oncogenic Potential of Salivary miRNA-93 and miRNA-412-3P in Oral Lichen Planus Patients
An observational study of Oral Lichen Planus and Oral Cancer, run by Moataz Mahmoud at 2 sites in Egypt.
Trial summary
Assessment The oncogenic potential of salivary microRNA-93 and microRNA-412-3p in oral lichen planus Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Oral Lichen Planus, Oral Cancer
- Type of treatment
- Pill or oral medicine
- How many people
- 60 participants
- Where
- 2 sitesEgypt
- Study dates
- 15 Jan 2023to 30 Sep 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 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Cases will be chosen clinically by taking patient history and clinical examination for all patients and histologically by taking incisional biopsy from the oral lesion to confirm the diagnosis of Oral Lichen Planus. Controls will be chosen without any oral systemic or oral lesions for accurate assessment and comparison of microRNA-93 and microRNA-412-3p between cases and controls
Who may be able to join
- Both genders with age range from 40 to 70 years.
- Clinically diagnosed and histologically confirmed as having symptomatic OLP.
- Patients who agree to sign a written consent after understanding the nature of the study
Who cannot join
- -Systemic and/or local systemic drug therapy within the last 3 months prior to the start of the study
- Patients on steroidal or non-steroidal anti-inflammatory drugs (NSAIDs) for at least the last 6 months
- Patients on Retinoid, green tea supplements or another natural products therapy
- Patients with already diagnosed malignant lesion/lesions
- Pregnant or Lactating females
- Vulnerable groups as prisoners, mentally disabled, etc…
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Facuty of Dentistry, CairoU
Cairo, 00202
Facuty of Dentistry, CairoU
Cairo, 002
About this study
Assessment The oncogenic potential of salivary microRNA-93 and microRNA-412-3p in oral lichen planus
Read the detailed description
Oral lichen planus is one of the most common prevalent muco-cutaneous chronic diseases. The disease is definitely auto-immune type .Despite having idiopathic etiology, many risk factors can be considered including systemic diseases, psychogenic diseases, dental restorations and some drugs.
The oral lesions are mainly bilateral, with frequent appearance in the inner buccal mucosa. It can be categorized into three forms; reticular form, atrophic form and bullous-erosive form.
The disease is considered as premalignant lesion as it has high potential of malignant transformation. T-lymphocytes infiltration in the basal cell layer of the epithelium and cytoid bodies are characteristic histopathologic features of the disease.
MicroRNAs (miRNAs) are endogenous short non-coding about 22 nucleotides RNAs in length. They perform major regulatory roles by targeting messenger RNAs (mRNAs) for cleavage or translational repression in animals and plants. they comprise one of the classes of gene regulatory molecules and definitely impact the output of many genes coding protein.
Previous studies have reported their critical role in development of various diseases in broad pathological conditions. Numerous studies have investigated the expression of miRNAs as diagnostic and prognostic biomarkers in potentially malignant diseased patients from human specimens, confirming these miRNAs as risk biomarkers for malignant transformation with excellent results.
miRNAs might make contribution as biomarkers for risk of development, for prognosis and response to treatment of oral cancer. Some studies have examined miRNA in Oral Lichen Planus (OLP) patients, not all of the have shown significant difference in miRNA changes, the role of miRNAs in malignant transformation of OLP is under examination.
MiR-93 is type of miRNAs within the miR-106b∼25 cluster. It has been reported that miRNA reinforced cell survival, corroborated sphere formation, amplified tumour growth, raised angiogenesis by enhancing endothelial cell activities and prevented apoptosis by targeting integrin-β8, a cell death-inducing antigen. These data suggested that miR-93 had important roles in carcinogenesis. Additionally, overexpression of miR-93 has been found in a broad range of cancers, including neuro-blastoma, non-small cell lung cancer, breast cancer and ovarian cancer. Furthermore, a significant increase in expression of miR-93has been detected in the saliva of OSCC patients compared to non-diseased participants. MiR-412-3p is beneficial in predicting cancer, focusing grave implications in cancer progression, and miR-412-3p was manifested to be highly expressed in extracellular vesicles from oral squamous cell carcinoma (OSCC) patients. MiRNA-93 and miRNA412-3p haven't been yet, according to our knowledge, experimented in Oral Lichen Planus patients, and they have been already assessed in OSCC patients. So, in our study, we assess the oncogenic potential of miR-93 and miR-412-3p in oral lichen patients, for more information about potential new tumour markers in Oral Lichen Planus.
- Conditions
- Oral Lichen Planus, Oral Cancer
- Keywords
- miRNA, Oral Lichen Planus, Oral Cancer
- Medical subject headings
- Lichen Planus, Oral, Mouth Neoplasms
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 1 | Oral Lichen Planus patients. Patients will be diagnosed clinically and histologically. | |
| Group 2 | Healthy patients. Patients without any systemic or oral lesions, not taking drugs for at least the the last 6 months | |
| Group 3 | Oral Squamous Cell Carcinoma |
What is being measured
The primary outcome is the main question the study is designed to answer.
miRNA-93
MicroRNA 93 is a functional RNA and a microRNA that in humans is encoded by the MIR93 (MicroRNA 93) gene
Measured: 2 years
miRNA-412-3P
microRNAs (miRNAs) are short (20-24 nt) non-coding RNAs that are involved in post-transcriptional regulation of gene expression in multicellular organisms by affecting both the stability and translation of mRNAs
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2022
- Study start15 Jan 2023
- Primary completion20 Sep 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral Lichen PlanusStudies of the same condition, open and under way.
- 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Moataz Mahmoud
- Sponsor type
- University, hospital or other
- Collaborators
- Cairo University
- Responsible party
- Sponsor-investigator, Moataz Mahmoud, Cairo University
- Investigators
- Moataz Taha, PhD student, Study director, Faculty of Dentistry, CairoUWeam Rashwan, Professor, Principal investigator, Faculty of Dentistry, CairoUOlfat Shaker, Professor, Study chair, Faculty of Medicine, CairoUInas Abdou, Lecturer, Study director, Center Of Radiation Oncology & Nuclear Medicine, CairoU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05400057
- Sponsor's protocol ID
- 6222
- Status last verified
- Oct 2023
- First submitted
- 27 May 2022
- Last updated
- 10 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Oncogenic Potential of Salivary miRNA-93 and miRNA-412-3P in Oral Lichen Planus Patients
- ClinicalTrials.gov ID
- NCT05400057
- Acronym / sponsor ID
- 6222
- Conditions
- Oral Lichen Planus, Oral Cancer
- Keywords
- miRNA, Oral Lichen Planus, Oral Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Moataz MahmoudUniversity, hospital or other
- Collaborators
- Cairo University
- Study start
- 15 Jan 2023 (actual)
- Primary completion
- 20 Sep 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 1 Jun 2022 (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.
Assessment The oncogenic potential of salivary microRNA-93 and microRNA-412-3p in oral lichen planus
Detailed description
Oral lichen planus is one of the most common prevalent muco-cutaneous chronic diseases. The disease is definitely auto-immune type .Despite having idiopathic etiology, many risk factors can be considered including systemic diseases, psychogenic diseases, dental restorations and some drugs.
The oral lesions are mainly bilateral, with frequent appearance in the inner buccal mucosa. It can be categorized into three forms; reticular form, atrophic form and bullous-erosive form.
The disease is considered as premalignant lesion as it has high potential of malignant transformation. T-lymphocytes infiltration in the basal cell layer of the epithelium and cytoid bodies are characteristic histopathologic features of the disease.
MicroRNAs (miRNAs) are endogenous short non-coding about 22 nucleotides RNAs in length. They perform major regulatory roles by targeting messenger RNAs (mRNAs) for cleavage or translational repression in animals and plants. they comprise one of the classes of gene regulatory molecules and definitely impact the output of many genes coding protein.
Previous studies have reported their critical role in development of various diseases in broad pathological conditions. Numerous studies have investigated the expression of miRNAs as diagnostic and prognostic biomarkers in potentially malignant diseased patients from human specimens, confirming these miRNAs as risk biomarkers for malignant transformation with excellent results.
miRNAs might make contribution as biomarkers for risk of development, for prognosis and response to treatment of oral cancer. Some studies have examined miRNA in Oral Lichen Planus (OLP) patients, not all of the have shown significant difference in miRNA changes, the role of miRNAs in malignant transformation of OLP is under examination.
MiR-93 is type of miRNAs within the miR-106b∼25 cluster. It has been reported that miRNA reinforced cell survival, corroborated sphere formation, amplified tumour growth, raised angiogenesis by enhancing endothelial cell activities and prevented apoptosis by targeting integrin-β8, a cell death-inducing antigen. These data suggested that miR-93 had important roles in carcinogenesis. Additionally, overexpression of miR-93 has been found in a broad range of cancers, including neuro-blastoma, non-small cell lung cancer, breast cancer and ovarian cancer. Furthermore, a significant increase in expression of miR-93has been detected in the saliva of OSCC patients compared to non-diseased participants. MiR-412-3p is beneficial in predicting cancer, focusing grave implications in cancer progression, and miR-412-3p was manifested to be highly expressed in extracellular vesicles from oral squamous cell carcinoma (OSCC) patients. MiRNA-93 and miRNA412-3p haven't been yet, according to our knowledge, experimented in Oral Lichen Planus patients, and they have been already assessed in OSCC patients. So, in our study, we assess the oncogenic potential of miR-93 and miR-412-3p in oral lichen patients, for more information about potential new tumour markers in Oral Lichen Planus.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| group 1 | – | –Oral Lichen Planus patients. Patients will be diagnosed clinically and histologically. |
| Group 2 | – | –Healthy patients. Patients without any systemic or oral lesions, not taking drugs for at least the the last 6 months |
| Group 3 | – | –Oral Squamous Cell Carcinoma |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Cases will be chosen clinically by taking patient history and clinical examination for all patients and histologically by taking incisional biopsy from the oral lesion to confirm the diagnosis of Oral Lichen Planus. Controls will be chosen without any oral systemic or oral lesions for accurate assessment and comparison of microRNA-93 and microRNA-412-3p between cases and controls
Key inclusion criteria (3 listed)
- Both genders with age range from 40 to 70 years.
- Clinically diagnosed and histologically confirmed as having symptomatic OLP.
- Patients who agree to sign a written consent after understanding the nature of the study
Key exclusion criteria (6 listed)
- -Systemic and/or local systemic drug therapy within the last 3 months prior to the start of the study
- Patients on steroidal or non-steroidal anti-inflammatory drugs (NSAIDs) for at least the last 6 months
- Patients on Retinoid, green tea supplements or another natural products therapy
- Patients with already diagnosed malignant lesion/lesions
- Pregnant or Lactating females
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
miRNA-93
Time frame: 2 years
MicroRNA 93 is a functional RNA and a microRNA that in humans is encoded by the MIR93 (MicroRNA 93) gene
miRNA-412-3P
Time frame: 2 years
microRNAs (miRNAs) are short (20-24 nt) non-coding RNAs that are involved in post-transcriptional regulation of gene expression in multicellular organisms by affecting both the stability and translation of mRNAs
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 10 Oct 2023.
- Individual participant dataSharing planned: Undecided
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Salivary IL-8 and Serum IL-6 as Biomarkers for Oral Potentially Malignant Disorders in Smokers and Never-Smokers
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Curcumin-mediated Photodynamic Therapy Versus Photobiomodulation in the Treatment of Oral Erosive Lichen Planus
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Adherence to Topical and Systemic Medications Among Symptomatic Oral Lichen Planus Patients: A Pilot Randomized Clinical Trial
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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.
Moataz Taha, PhD student study director
Faculty of Dentistry, CairoU
Weam Rashwan, Professor principal investigator
Faculty of Dentistry, CairoU
Olfat Shaker, Professor study chair
Faculty of Medicine, CairoU
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oral Lichen Planus and Oral Cancer, run by Moataz Mahmoud at 2 sites 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 6 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 10 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
miRNA-93 (time frame: 2 years). The study lists 2 primary outcomes in all. 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 10 Oct 2023.