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

NCT05400057 | Completed DMC

• 1 other identifier: 6222
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Oral Lichen Planus; Oral Cancer

Keywords

miRNA; Oral Lichen Planus; Oral Cancer

Outcome Measures

Primary Outcomes (2)

• miRNA-93

  MicroRNA 93 is a functional RNA and a microRNA that in humans is encoded by the MIR93 (MicroRNA 93) gene

  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

  2 years

Study Arms (3)

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

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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…

Sponsors & Collaborators

• Moataz Mahmoud: lead
• Cairo University: collaborator

Study Sites (2)

Facuty of Dentistry, CairoU

Cairo, 00202, Egypt

Location

Facuty of Dentistry, CairoU

Cairo, 002, Egypt

Location

MeSH Terms

Conditions

Lichen Planus, Oral; Mouth Neoplasms

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Lichen Planus; Lichenoid Eruptions; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms

Study Officials

• Moataz Taha, PhD student

  Faculty of Dentistry, CairoU

  STUDY DIRECTOR

• Weam Rashwan, Professor

  Faculty of Dentistry, CairoU

  PRINCIPAL INVESTIGATOR

• Olfat Shaker, Professor

  Faculty of Medicine, CairoU

  STUDY CHAIR

• Inas Abdou, Lecturer

  Center Of Radiation Oncology & Nuclear Medicine, CairoU

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 27, 2022
• First Posted: June 1, 2022
• Study Start: January 15, 2023
• Primary Completion: September 20, 2023
• Study Completion: September 30, 2023
• Last Updated: October 10, 2023

Record last verified: 2023-10

Locations

EG (2)