Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2026-02-25 @ 7:36 PM
Study NCT ID:
NCT02834520
Status:
COMPLETED
Last Update Posted:
2016-07-15
First Post:
2016-07-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Expression of miRNa-138 and Cyclin D1 in Oral Mucosa of Patients With Oral Lichen Planus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017676', 'term': 'Lichen Planus, Oral'}], 'ancestors': [{'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D008010', 'term': 'Lichen Planus'}, {'id': 'D017512', 'term': 'Lichenoid Eruptions'}, {'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'oral mucosa tissue specimen'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-07-14', 'studyFirstSubmitDate': '2016-07-13', 'studyFirstSubmitQcDate': '2016-07-14', 'lastUpdatePostDateStruct': {'date': '2016-07-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-07-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'expression of miRNA-138', 'timeFrame': '1 day', 'description': 'expression of miRNA-138 in oral mucosa of patients with oral lichen planus'}], 'secondaryOutcomes': [{'measure': 'gene expression of cyclin D1', 'timeFrame': '1 day', 'description': 'gene expression of cyclin D1 in oral mucosa of patients with oral lichen planus'}, {'measure': 'protein expression of cyclin D1', 'timeFrame': '1 day', 'description': 'protein expression of cyclin D1 in oral mucosa of patients with oral lichen planus'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Oral Lichen Planus']}, 'referencesModule': {'references': [{'pmid': '20232393', 'type': 'RESULT', '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. 2010 Aug 1;127(3):505-12. doi: 10.1002/ijc.25320.'}, {'pmid': '19540661', 'type': 'RESULT', '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.'}, {'pmid': '23445815', 'type': 'RESULT', '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.'}, {'pmid': '22739938', 'type': 'RESULT', '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 1;11(13):2495-506. doi: 10.4161/cc.20898. Epub 2012 Jul 1.'}, {'pmid': '18024283', 'type': 'RESULT', '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.'}, {'pmid': '12076323', 'type': 'RESULT', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '45 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with oral lichen planus.\n\nExclusion Criteria:\n\n* any systemic disease other than oral lichen planus.\n* smokers.\n* pregnant females.\n* periodontal diseases.'}, 'identificationModule': {'nctId': 'NCT02834520', 'briefTitle': 'Expression of miRNa-138 and Cyclin D1 in Oral Mucosa of Patients With Oral Lichen Planus', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Expression of miRNA-138 and Cyclin D1 in Oral Lichen Planus (A Study Utilizing Immunohistochemistry and Real-time Polymerase Chain Reaction)', 'orgStudyIdInfo': {'id': 'MiRNA-138_cyclin D1_OLP'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'oral lichen planus', 'description': '30 patients suffering from reticular, erosive and atrophic oral lichen planus'}, {'label': 'control subjects', 'description': '30 individuals age, gender and periodontal status matched with oral lichen planus patients and not suffering from any oral mucosal lesions or periodontal disease.'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Noha Ghallab, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Associate Professor of periodontology and Oral Medicine faulty of oral an'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Oral Medicine and Periodontology', 'investigatorFullName': 'Noha Ayman Ghallab', 'investigatorAffiliation': 'Cairo University'}}}}