Ignite Creation Date:
2025-12-24 @ 5:39 PM
Ignite Modification Date:
2025-12-25 @ 3:09 PM
Study NCT ID:
NCT00218868
Status:
COMPLETED
Last Update Posted:
2023-12-29
First Post:
2005-09-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cytodiagnosis of Basal Cell Carcinoma and Actinic Keratosis Using Papanicolaou and May-grunwald-giemsa Stained Tissue Smear
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002280', 'term': 'Carcinoma, Basal Cell'}, {'id': 'D017499', 'term': 'Porokeratosis'}], 'ancestors': [{'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D018295', 'term': 'Neoplasms, Basal Cell'}, {'id': 'D012873', 'term': 'Skin Diseases, Genetic'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D007642', 'term': 'Keratosis'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 66}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2007-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-28', 'studyFirstSubmitDate': '2005-09-20', 'studyFirstSubmitQcDate': '2005-09-20', 'lastUpdatePostDateStruct': {'date': '2023-12-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2005-09-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-02', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cytodiagnosis', 'Skin Scrape', 'Touch Imprint', 'Papanicolaou', 'May-Grunvald-Giemsa'], 'conditions': ['Carcinoma, Basal Cell', 'Porokeratosis, Disseminated Superficial Actinic']}, 'referencesModule': {'references': [{'pmid': '17916094', 'type': 'RESULT', 'citation': 'Christensen E, Bofin A, Gudmundsdottir I, Skogvoll E. Cytological diagnosis of basal cell carcinoma and actinic keratosis, using Papanicolaou and May-Grunwald-Giemsa stained cutaneous tissue smear. Cytopathology. 2008 Oct;19(5):316-22. doi: 10.1111/j.1365-2303.2007.00483.x. Epub 2007 Oct 4.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare and evaluate the diagnostic performance of scrape cytology using two different cytological staining techniques, and to evaluate additional touch imprint cytology with that of histopathology of superficial basal cell carcinoma and actinic keratosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '105 Years', 'minimumAge': '0 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '50 BCC and 28 AK histologically verified lesions, from 41 and 25 patients, respectively', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nHistologically verified basal call carcinoma and actinic keratosis\n\nExclusion Criteria:\n\nMorphea form of basal cell carcinoma. Pigmented form of basal cell carcinoma.'}, 'identificationModule': {'nctId': 'NCT00218868', 'briefTitle': 'Cytodiagnosis of Basal Cell Carcinoma and Actinic Keratosis Using Papanicolaou and May-grunwald-giemsa Stained Tissue Smear', 'organization': {'class': 'OTHER', 'fullName': 'Norwegian University of Science and Technology'}, 'officialTitle': 'Cytodiagnosis of Basal Cell Carcinoma and Actinic Keratosis Using Papanicolaou and May-grunvald-giemsa Stained Cutaneous Tissue Smear in Relation to Photodynamic Therapy', 'orgStudyIdInfo': {'id': 'EC-001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'skin scrape', 'interventionNames': ['Procedure: Skin scrape']}], 'interventions': [{'name': 'Skin scrape', 'type': 'PROCEDURE', 'description': 'scrape cytology using two different cytological staining techniques, and additional touch imprint cytology compared with histopathology of superficial basal cell carcinoma and actinic keratosis', 'armGroupLabels': ['skin scrape']}]}, 'contactsLocationsModule': {'locations': [{'zip': '7006', 'city': 'Trondheim', 'country': 'Norway', 'facility': 'St. Olav University Hospital', 'geoPoint': {'lat': 63.43049, 'lon': 10.39506}}], 'overallOfficials': [{'name': 'Eidi Christensen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'St. Olav, University Hospital, Trondheim'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Norwegian University of Science and Technology', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}