Ignite Creation Date:
2025-12-26 @ 11:00 AM
Ignite Modification Date:
2026-01-01 @ 2:22 AM
Study NCT ID:
NCT00472706
Status:
TERMINATED
Last Update Posted:
2010-05-13
First Post:
2007-05-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trial of Excision Versus Photodynamic Therapy in the Treatment of Bowen's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Netherlands']}, 'conditionBrowseModule': {'meshes': [{'id': 'D001913', 'term': "Bowen's Disease"}], 'ancestors': [{'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D018307', 'term': 'Neoplasms, Squamous Cell'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010778', 'term': 'Photochemotherapy'}], 'ancestors': [{'id': 'D003131', 'term': 'Combined Modality Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D010789', 'term': 'Phototherapy'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 65}}, 'statusModule': {'whyStopped': 'Study stopped because of disappointing inclusion rates', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2007-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-05', 'completionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-05-12', 'studyFirstSubmitDate': '2007-05-10', 'studyFirstSubmitQcDate': '2007-05-10', 'lastUpdatePostDateStruct': {'date': '2010-05-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-05-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'recurrence rate', 'timeFrame': 'two years'}], 'secondaryOutcomes': [{'measure': 'cosmetic outcome', 'timeFrame': 'one year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Treatment', 'Excision', 'Photodynamic therapy', 'Recurrence rate', 'Cosmetic outcome'], 'conditions': ["Bowen's Disease"]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to identify the most optimal therapy for Bowen's disease: excision versus Photodynamic therapy.", 'detailedDescription': "The study is a randomized clinical trial in which two treatment options for Bowen's disease, excision and photodynamic therapy, are compared on recurrence rate, cosmesis en expenses."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age \\> 18 years\n* Histological proven Bowen's disease on scalp, face, trunk, arms and legs\n* Informed Consent\n\nExclusion Criteria:\n\n* Recurrent Bowen's disease\n* Anogenital or subungual Bowe's disease\n* Other skin malignancy in the same area\n* Porphyria"}, 'identificationModule': {'nctId': 'NCT00472706', 'briefTitle': "Trial of Excision Versus Photodynamic Therapy in the Treatment of Bowen's Disease", 'organization': {'class': 'OTHER', 'fullName': 'Catharina Ziekenhuis Eindhoven'}, 'officialTitle': "A Randomized Clinical Trial of Excision Versus Photodynamic Therapy in Bowen's Disease", 'orgStudyIdInfo': {'id': 'M06-16107'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'Excision', 'interventionNames': ['Procedure: excision']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Photodynamic therapy', 'interventionNames': ['Procedure: Photodynamic therapy']}], 'interventions': [{'name': 'excision', 'type': 'PROCEDURE', 'description': 'excision 3 mm margin', 'armGroupLabels': ['1']}, {'name': 'Photodynamic therapy', 'type': 'PROCEDURE', 'description': 'Photodynamic therapy', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Annette Verzijl, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Catharina hospital/Erasmus MC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Catharina Ziekenhuis Eindhoven', 'class': 'OTHER'}, 'collaborators': [{'name': 'Erasmus Medical Center', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Drs. A. Verzijl', 'oldOrganization': 'Catharina hospital/Erasmus MC'}}}}