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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02834520
Other study ID # MiRNA-138_cyclin D1_OLP
Secondary ID
Status Completed
Phase N/A
First received July 13, 2016
Last updated July 14, 2016
Start date May 2015
Est. completion date March 2016

Study information

Verified date July 2016
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority Egypt: Institutional Review Board
Study type Observational

Clinical Trial Summary

60 individuals were subdivided into 2 groups, 30 patients with oral lichen planus, 30 control individuals. Expression of miRNA-138 and cyclin D1 were evaluated in oral mucosa utilizing Quantitative real-time polymerase chain reaction and immunohistochemistry.


Description:

60 individuals were subdivided into 3 groups, into 2 groups, 30 patients with oral lichen planus, 30 control individuals having age, gender and periodontal status matched with both patients groups acting as a control group. Relative gene expression of miRNA-138 was estimated using Quantitative real-time polymerase chain reaction technique in oral mucosa of both oral lichen planus patients and control subjects. Sub grouping of oral lichen planus patients were performed into reticular, atrophic and erosive groups (n=10 each). Cyclin D1 gene expression was estimated using Quantitative real-time polymerase chain reaction technique and Cyclin D1 protein level was estimated using immunohistochemistry.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date March 2016
Est. primary completion date December 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 45 Years to 65 Years
Eligibility Inclusion Criteria:

- patients with oral lichen planus.

Exclusion Criteria:

- any systemic disease other than oral lichen planus.

- smokers.

- pregnant females.

- periodontal diseases.

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

References & Publications (6)

Hirota M, Ito T, Okudela K, Kawabe R, Yazawa T, Hayashi H, Nakatani Y, Fujita K, Kitamura H. Cell proliferation activity and the expression of cell cycle regulatory proteins in oral lichen planus. J Oral Pathol Med. 2002 Apr;31(4):204-12. — View Citation

Jiang L, Liu X, Kolokythas A, Yu J, Wang A, Heidbreder CE, Shi F, Zhou X. Downregulation of the Rho GTPase signaling pathway is involved in the microRNA-138-mediated inhibition of cell migration and invasion in tongue squamous cell carcinoma. Int J Cancer — View Citation

Jin Y, Chen D, Cabay RJ, Wang A, Crowe DL, Zhou X. Role of microRNA-138 as a potential tumor suppressor in head and neck squamous cell carcinoma. Int Rev Cell Mol Biol. 2013;303:357-85. doi: 10.1016/B978-0-12-407697-6.00009-X. Review. — View Citation

Liu X, Jiang L, Wang A, Yu J, Shi F, Zhou X. MicroRNA-138 suppresses invasion and promotes apoptosis in head and neck squamous cell carcinoma cell lines. Cancer Lett. 2009 Dec 28;286(2):217-22. doi: 10.1016/j.canlet.2009.05.030. Epub 2009 Jun 21. — View Citation

Liu X, Lv XB, Wang XP, Sang Y, Xu S, Hu K, Wu M, Liang Y, Liu P, Tang J, Lu WH, Feng QS, Chen LZ, Qian CN, Bei JX, Kang T, Zeng YX. MiR-138 suppressed nasopharyngeal carcinoma growth and tumorigenesis by targeting the CCND1 oncogene. Cell Cycle. 2012 Jul — View Citation

Yao X, Yin C, Shen LJ, Xie SM. [Expressions of NF--kappaBp65, TRAF2, cyclinD1 and their association with cell apoptosis in oral lichen planus]. Nan Fang Yi Ke Da Xue Xue Bao. 2007 Nov;27(11):1657-60. Chinese. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary expression of miRNA-138 expression of miRNA-138 in oral mucosa of patients with oral lichen planus 1 day No
Secondary gene expression of cyclin D1 gene expression of cyclin D1 in oral mucosa of patients with oral lichen planus 1 day No
Secondary protein expression of cyclin D1 protein expression of cyclin D1 in oral mucosa of patients with oral lichen planus 1 day No
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