Ignite Creation Date:
2025-12-25 @ 3:45 AM
Ignite Modification Date:
2026-01-12 @ 1:51 PM
Study NCT ID:
NCT05324202
Status:
UNKNOWN
Last Update Posted:
2022-04-12
First Post:
2021-10-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
New Imaging Procedures and Therapeutic Approach in Basal Cell Carcinoma Management
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002280', 'term': 'Carcinoma, Basal Cell'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2023-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-04-05', 'studyFirstSubmitDate': '2021-10-05', 'studyFirstSubmitQcDate': '2022-04-05', 'lastUpdatePostDateStruct': {'date': '2022-04-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Treatment efficacy of Nd:YAG Laser 1064-nm for low risk basal cell carcinomas', 'timeFrame': '8 weeks after the treatment', 'description': 'Clearance rate of basal cell carcinomas after 1-3 Nd:YAG laser treatments evaluated by clinical inspectation, dermatosopy and optical coherence tomography.'}, {'measure': 'Recurrence Rate after Nd:YAG Laser treatment', 'timeFrame': '12 months', 'description': 'To assess the recurrence rate after a long-term follow-up of 6 and 12 months'}], 'secondaryOutcomes': [{'measure': 'Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)', 'timeFrame': '6 and 12 months after treatment', 'description': 'To assess treatment tolerability of the Nd:YAG Laser 1064-nm (e.g. pain according to a Numerical rating scale, scarring, wound healing, secondary infection rate)'}, {'measure': 'Cosmetic outcome after laser treatment', 'timeFrame': '6 and 12 months after treatment', 'description': 'This will be assess according to an assessment scale including following parameters:\n\n* Pigmentation: hyperpigmentation, hypopigmentation, normal\n* Vascularity: pink, red, purple, normal\n* Pliability: firm, contracture, supple, yielding, ropes, normal\n* Scarring: yes, no\n* Overall opinion: Rating on a scale from 1-5 (school note system) Separate evaluation of observer and patient.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Basal Cell Carcinoma']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to show that the Nd:YAG laser could be a promising alternative treatment option in the management of low-risk basal cell carcinomas with similar high efficacy rates to surgery, and low recurrence rates evaluated over a time period of one year. Reflectance confocal microscopy, optical coherence tomography and clinical examination are used prior to confirm the clinical diagnosis of the basal cell carcinoma and for premargination of the tumor. The optical coherence tomography will also be used post treatment to confirm clearance of the basal cell carcinoma and to monitor treatment response.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients with one or more basal cell carcinoma(s) on head, trunk or extremities\n\n* Diagnosed clinically, with a dermatoscope and through noninvasive imaging methods such as reflectance confocal microscopy and optical coherence tomography\n* H zone \\<6mm, M zone \\<10mm, L zone \\<20mm\n* Tumor thickness \\<2mm\n* Clearly visible margins\n\nExclusion Criteria:\n\n* Pregnancy\n* \\<18 years of age\n* Current or history of immunosuppression\n* Prior-treatment of the basal cell carcinoma/ recurrent basal cell carcinomas\n* History of radiation in the area of basal cell carcinoma appearance'}, 'identificationModule': {'nctId': 'NCT05324202', 'briefTitle': 'New Imaging Procedures and Therapeutic Approach in Basal Cell Carcinoma Management', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Vienna'}, 'officialTitle': 'New Imaging Procedures and Therapeutic Approach in Basal Cell Carcinoma', 'orgStudyIdInfo': {'id': 'Ndyag_BCC_1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Nd:YAG treatment arm', 'interventionNames': ['Device: Cynosure Cynergy Nd:YAG Laser 1064nm']}], 'interventions': [{'name': 'Cynosure Cynergy Nd:YAG Laser 1064nm', 'type': 'DEVICE', 'description': 'The Nd:YAG Laser 1064nm is intended to be used as a treatment option in individuals suffering from low-risk basal cell carcinoma(s).', 'armGroupLabels': ['Nd:YAG treatment arm']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dr. Stephanie Geisler', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Investigator, Resident in Dermatology', 'investigatorFullName': 'Dr. Stephanie Geisler', 'investigatorAffiliation': 'Medical University of Vienna'}}}}