NCT02834520

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2015

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 13, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 15, 2016

Completed
Last Updated

July 15, 2016

Status Verified

July 1, 2016

Enrollment Period

7 months

First QC Date

July 13, 2016

Last Update Submit

July 14, 2016

Conditions

Oral Lichen Planus

Outcome Measures

Primary Outcomes (1)

  • expression of miRNA-138

    expression of miRNA-138 in oral mucosa of patients with oral lichen planus

    1 day

Secondary Outcomes (2)

  • gene expression of cyclin D1

    1 day

  • protein expression of cyclin D1

    1 day

Study Arms (2)

oral lichen planus

30 patients suffering from reticular, erosive and atrophic oral lichen planus

control subjects

30 individuals age, gender and periodontal status matched with oral lichen planus patients and not suffering from any oral mucosal lesions or periodontal disease.

Eligibility Criteria

Age45 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

60 individuals were subdivided into 2 groups, 30 patients suffering from oral lichen planus and 30 individuals having age, gender and periodontal status matched with both patients groups acting as a control group.

You may qualify if:

  • patients with oral lichen planus.

You may not qualify if:

  • any systemic disease other than oral lichen planus.
  • smokers.
  • pregnant females.
  • periodontal diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • 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. 2010 Aug 1;127(3):505-12. doi: 10.1002/ijc.25320.

    PMID: 20232393RESULT

  • 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.

    PMID: 19540661RESULT

  • 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.

    PMID: 23445815RESULT

  • 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 1;11(13):2495-506. doi: 10.4161/cc.20898. Epub 2012 Jul 1.

    PMID: 22739938RESULT

  • 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.

    PMID: 18024283RESULT

  • 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. doi: 10.1034/j.1600-0714.2002.310403.x.

    PMID: 12076323RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

oral mucosa tissue specimen

MeSH Terms

Conditions

Lichen Planus, Oral

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesLichen PlanusLichenoid EruptionsSkin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Noha Ghallab, MD

    Associate Professor of periodontology and Oral Medicine faulty of oral an

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Oral Medicine and Periodontology

Study Record Dates

First Submitted

July 13, 2016

First Posted

July 15, 2016

Study Start

May 1, 2015

Primary Completion

December 1, 2015

Study Completion

March 1, 2016

Last Updated

July 15, 2016

Record last verified: 2016-07