the Oncogenic Potential of Salivary miRNA-93 and miRNA-412-3P in Oral Lichen Planus Patients
NCT ID: NCT05400057
Last Updated: 2023-10-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
60 participants
OBSERVATIONAL
2023-01-15
2023-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Diagnostic Accuracy of lncRNA DQ786243 and miRNA146a in Saliva of Oral Potentially Malignant Lesions
NCT05730855
The Senstivity and Specificity of Using Salivary miRNAs in Detection of Malignant Transformation of Oral Lesions.
NCT04913545
Exfoliated Cytology in Detection of Oral Premalignant and Malignant Lesions
NCT04955197
Salivary and Serum Levels of Chemerin and MMP-9 in Oral Premalignant and Malignant Lesions
NCT02323672
The Oral Microbiome as a Prognostic Tool in Oral Malignant and Premalignant Lesions and in Medication Related Osteonecrosis of the Jaw
NCT03418454
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_CONTROL
RETROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
group 1
Oral Lichen Planus patients. Patients will be diagnosed clinically and histologically.
No interventions assigned to this group
Group 2
Healthy patients. Patients without any systemic or oral lesions, not taking drugs for at least the the last 6 months
No interventions assigned to this group
Group 3
Oral Squamous Cell Carcinoma
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Clinically diagnosed and histologically confirmed as having symptomatic OLP.
* Patients who agree to sign a written consent after understanding the nature of the study
Exclusion Criteria
* 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…
40 Years
70 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Cairo University
OTHER
Moataz Mahmoud
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Moataz Mahmoud
Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Moataz Taha, PhD student
Role: STUDY_DIRECTOR
Faculty of Dentistry, CairoU
Weam Rashwan, Professor
Role: PRINCIPAL_INVESTIGATOR
Faculty of Dentistry, CairoU
Olfat Shaker, Professor
Role: STUDY_CHAIR
Faculty of Medicine, CairoU
Inas Abdou, Lecturer
Role: STUDY_DIRECTOR
Center Of Radiation Oncology & Nuclear Medicine, CairoU
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Facuty of Dentistry, CairoU
Cairo, , Egypt
Facuty of Dentistry, CairoU
Cairo, , Egypt
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
6222
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.