Clinical trial NCT05400057: the Oncogenic Potential of Salivary miRNA-93 and miRNA-412-3P in Oral Lichen Planus Patients
Official title: the Oncogenic Potential of Salivary miRNA-93 and miRNA-412-3P in Oral Lichen Planus Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Oral Lichen Planus
Oral Cancer
Keywords: miRNA
Oral Lichen Planus
Oral Cancer
Lead sponsor: Cairo University
Sponsor class: OTHER
Collaborators: name: Cairo University
First posted: 2022-06-01
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* -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...

Primary outcomes:
measure: miRNA-93
timeFrame: 2 years
measure: miRNA-412-3P
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Facuty of Dentistry, CairoU
city: Cairo
country: Egypt
facility: Facuty of Dentistry, CairoU
Study officials:
affiliation: Faculty of Dentistry, CairoU
name: Moataz Taha, PhD student
role: STUDY_DIRECTOR
affiliation: Faculty of Dentistry, CairoU
name: Weam Rashwan, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Faculty of Medicine, CairoU
name: Olfat Shaker, Professor
role: STUDY_CHAIR
affiliation: Center Of Radiation Oncology & Nuclear Medicine, CairoU
name: Inas Abdou, Lecturer
role: STUDY_DIRECTOR
References: