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

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-15

Study Completion Date

2023-09-30

Brief Summary

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Assessment The oncogenic potential of salivary microRNA-93 and microRNA-412-3p in oral lichen planus

Detailed Description

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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

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Oral Lichen Planus Oral Cancer

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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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

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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…
Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role collaborator

Moataz Mahmoud

OTHER

Sponsor Role lead

Responsible Party

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Moataz Mahmoud

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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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

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Facuty of Dentistry, CairoU

Cairo, , Egypt

Site Status

Facuty of Dentistry, CairoU

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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6222

Identifier Type: -

Identifier Source: org_study_id

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