the Oncogenic Potential of Salivary miRNA-93 and miRNA-412-3P in Oral Lichen Planus Patients

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Brief Title

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

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.
    


Study Type

Observational


Primary Outcome

miRNA-93


Condition

Oral Lichen Planus


Study Arms / Comparison Groups

 group 1
Description:  Oral Lichen Planus patients. Patients will be diagnosed clinically and histologically.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

60

Start Date

July 15, 2022

Completion Date

October 30, 2022

Primary Completion Date

September 20, 2022

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…
      

Gender

All

Ages

40 Years - 70 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Weam Rashwan, Professor, 01025026920, [email protected]

Location Countries

Egypt

Location Countries

Egypt

Administrative Informations


NCT ID

NCT05400057

Organization ID

6222


Responsible Party

Sponsor-Investigator

Study Sponsor

Moataz Mahmoud

Collaborators

 Cairo University

Study Sponsor

Weam Rashwan, Professor, Study Chair, Cairo University


Verification Date

June 2022