Ignite Creation Date:
2025-12-24 @ 4:32 PM
Ignite Modification Date:
2026-01-22 @ 11:36 PM
Study NCT ID:
NCT02532166
Status:
UNKNOWN
Last Update Posted:
2015-08-25
First Post:
2015-08-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Incidence of Esophageal Lichen Planus in Patients With Known Oral Lichen Planus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008010', 'term': 'Lichen Planus'}], 'ancestors': [{'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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-08-24', 'studyFirstSubmitDate': '2015-08-17', 'studyFirstSubmitQcDate': '2015-08-24', 'lastUpdatePostDateStruct': {'date': '2015-08-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-08-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Value of additional endoscopic enhancing imaging methods for detection of esophageal lichen planus.', 'timeFrame': '3-5 years'}], 'secondaryOutcomes': [{'measure': 'Natural long-term incidence of esophageal lichen planus in patients with known oral lichen.', 'timeFrame': '3-5'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['narrow band imaging', 'Chromoendoscopy', 'Lugol'], 'conditions': ['Lichen Planus']}, 'referencesModule': {'references': [{'pmid': '19280529', 'type': 'BACKGROUND', 'citation': 'Quispel R, van Boxel OS, Schipper ME, Sigurdsson V, Canninga-van Dijk MR, Kerckhoffs A, Smout AJ, Samsom M, Schwartz MP. High prevalence of esophageal involvement in lichen planus: a study using magnification chromoendoscopy. Endoscopy. 2009 Mar;41(3):187-93. doi: 10.1055/s-0028-1119590. Epub 2009 Mar 11.'}]}, 'descriptionModule': {'briefSummary': 'The lichen planus is a mucocutaneous disease of unknown etiology with an incidence of 1-2%, that affects in 30-70% of cases either the mucosa of the mouth, or partly in combination with infection of the skin, the oral with his known premalignant potential in up to 2-3% predisposed to the development of an oral squamous cell carcinoma.In rare cases, there is also an manifestation of the lining of the esophagus, which can then be associated with symptomatic strictures of the esophagus.\n\nThe value of moreover increasingly established endoscopic imaging procedures are investigated as well as data of the natural long-term outcome in esophageal lichen planus infestation especially in view of malignant transformation.', 'detailedDescription': 'The lichen planus is a mucocutaneous disease of unknown etiology that manifests itself with an incidence of 1-2% in 30-70% of cases either at the mucosa of the mouth, or partly in combination with infection of the skin, the oral with his known premalignant potential in up to 2-3% predisposed to the development of an oral squamous cell carcinoma. In rare cases, there is also an manifestation of the lining of the esophagus, which can then be associated with symptomatic strictures of the esophagus. In addition, four cases have been reported with esophageal squamous cell carcinoma in patients with esophageal lichen planus.\n\nThe value of moreover increasingly established use of narrow-band imaging (a process for improving the detection of early cancers in the gastrointestinal tract by creating a maximum contrast between outright and altered mucosa, which could have already shown an improved detection rate of early lesions of the esophagus as well as squamous cell carcinoma), or the chromoendoscopy has means for example Lugol solution in correlation to the histopathologic findings in lichen planus), has not been investigated to date.\n\nAlso, data of the natural long-term outcome in esophageal lichen planus infestation especially in view of malignant transformation are currently not available.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years\n* Known lichen planus of the oral mucosa\n\nExclusion Criteria:\n\n* Severe cardiopulmonary disease - ASA (American Society of Anaesthesiology) class \\> III\n* Antisecretory and nonsteroidal anti-inflammatory medication within the last month'}, 'identificationModule': {'nctId': 'NCT02532166', 'briefTitle': 'Incidence of Esophageal Lichen Planus in Patients With Known Oral Lichen Planus', 'organization': {'class': 'OTHER', 'fullName': 'Ruhr University of Bochum'}, 'officialTitle': 'Incidence of Esophageal Lichen Planus in Patients With Known Oral Lichen Planus. Diagnostic Value of White Light Endoscopy, Narrow Band Imaging and Chromoendoscopy for Detection of Esophageal Manifestation in Patients With Oral Lichen.', 'orgStudyIdInfo': {'id': '2011-4072'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Esophageal lichen planus', 'description': 'White light endoscopy compared to narrow band imaging and chromoendoscopy with Lugol for detection of esophageal lichen.', 'interventionNames': ['Other: Esophageal lichen planus']}], 'interventions': [{'name': 'Esophageal lichen planus', 'type': 'OTHER', 'description': 'White light endoscopy compared to narrow band imaging and Lugol for detection of esophageal lichen.', 'armGroupLabels': ['Esophageal lichen planus']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44892', 'city': 'Bochum', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Pohl Michael, MD', 'role': 'CONTACT', 'email': 'michael.pohl@rub.de', 'phone': '0049 234 299', 'phoneExt': '0'}, {'name': 'Michael Steckstor, MD', 'role': 'CONTACT', 'email': 'miachel.steckstor@rub.de', 'phone': '0049 234 299', 'phoneExt': '0'}], 'facility': 'Department of Medicine', 'geoPoint': {'lat': 51.48165, 'lon': 7.21648}}, {'zip': '30880', 'city': 'Laatzen', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Andrea Riphaus, PD MD', 'role': 'CONTACT', 'email': 'ariphaus@web.de', 'phone': '0049 511 8208', 'phoneExt': '2400'}, {'name': 'Pohl Michale, MD', 'role': 'CONTACT', 'email': 'michael.pohl@rub.de', 'phone': '0049 511 299', 'phoneExt': '0'}], 'facility': 'Klinikum Agness Karll Laatzen', 'geoPoint': {'lat': 52.31506, 'lon': 9.79739}}], 'centralContacts': [{'name': 'Andrea Riphaus, PD MD', 'role': 'CONTACT', 'email': 'ariphaus@web.de', 'phone': '0049 511 8208', 'phoneExt': '2400'}, {'name': 'Pohl Michael, MF', 'role': 'CONTACT', 'email': 'Michael.pohl@rub.de', 'phone': '0049 0234 299', 'phoneExt': '0'}], 'overallOfficials': [{'name': 'Andrea Riphaus, PD Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Medicine, KRH Laatzen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ruhr University of Bochum', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PD Dr. Andrea Riphaus', 'investigatorFullName': 'Andrea Riphaus', 'investigatorAffiliation': 'Ruhr University of Bochum'}}}}