Ignite Creation Date:
2025-12-24 @ 4:34 PM
Ignite Modification Date:
2026-02-26 @ 4:19 PM
Study NCT ID:
NCT03024866
Status:
COMPLETED
Last Update Posted:
2025-02-06
First Post:
2017-01-11
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparison of eBX and Mohs Surgery for Treatment of Early-stage Non-melanoma Skin Cancer a Matched Pair Cohort Study.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015580', 'term': 'Mohs Surgery'}], 'ancestors': [{'id': 'D008866', 'term': 'Microsurgery'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D062109', 'term': 'Dermatologic Surgical Procedures'}, {'id': 'D019651', 'term': 'Plastic Surgery Procedures'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'rob.burnside@elekta.com', 'phone': '14084931533', 'title': 'Robert Burnside', 'organization': 'Xoft Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Patients have been followed for 2.6 to 4.3 years after EBT, and 2.3 to 5 years following MMS.', 'description': 'All additional adverse events that were collected have been reported. The only adverse events reported were all skin toxicities from CTCAE.', 'eventGroups': [{'id': 'EG000', 'title': 'Mohs Surgery', 'description': 'Previously completed treatment for non-melanoma skin cancer using Mohs Surgery', 'otherNumAtRisk': 181, 'deathsNumAtRisk': 181, 'otherNumAffected': 79, 'seriousNumAtRisk': 181, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Electronic Brachytherapy', 'description': 'Previously completed treatment for non-melanoma skin cancer using Xoft eBx Electronic Brachytherapy System', 'otherNumAtRisk': 188, 'deathsNumAtRisk': 188, 'otherNumAffected': 107, 'seriousNumAtRisk': 188, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Late toxicities', 'notes': 'hypopigmentation, hyperpigmentation, erythematous car, telangiectasia, hair loss, fibrosis, atrophy, loss of subcutaneous tissue, hypertrophy/keloid, poor healing/ulceration/erosion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 181, 'numEvents': 181, 'numAffected': 79}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 188, 'numAffected': 107}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Absence of Local Recurrence at Treatment Site(s) Greater or Equal to 3 Years Follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'OG000'}, {'value': '181', 'groupId': 'OG001'}]}, {'units': 'Lesions Analyzed', 'counts': [{'value': '208', 'groupId': 'OG000'}, {'value': '208', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Electronic Brachytherapy', 'description': 'Previously completed treatment of 1 or more lesions per participant for non-melanoma skin cancer using Xoft eBx Electronic Brachytherapy System\n\nElectronic Brachytherapy: High-dose-rate electronic brachytherapy (EBT) provides a non-surgical treatment option for non-melanoma skin cancer (NMSC). This matched-pair cohort study compared the outcomes of treatment with EBT to those of Mohs surgery in patients with NMSC.'}, {'id': 'OG001', 'title': 'Mohs Surgery', 'description': 'Previously completed treatment of 1 or more lesions per participant for non-melanoma skin cancer using Mohs Surgery\n\nElectronic Brachytherapy: High-dose-rate electronic brachytherapy (EBT) provides a non-surgical treatment option for non-melanoma skin cancer (NMSC). This matched-pair cohort study compared the outcomes of treatment with EBT to those of Mohs surgery in patients with NMSC.'}], 'classes': [{'title': 'Participants Analyzed', 'categories': [{'measurements': [{'value': '188', 'groupId': 'OG000'}, {'value': '181', 'groupId': 'OG001'}]}]}, {'title': 'Absence of Local Recurrence', 'categories': [{'measurements': [{'value': '187', 'groupId': 'OG000'}, {'value': '181', 'groupId': 'OG001'}]}]}, {'title': 'Lesions Analyzed', 'categories': [{'measurements': [{'value': '208', 'groupId': 'OG000'}, {'value': '208', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Range greater or equal to 3 years post last Xoft eBx or MMS treatment at the time of study start at1 long-term prospective visit by study completion.', 'description': 'Subjects treated with Xoft eBx or MMS over 3 years prior were called in for a long-term prospective visit, consented, and assessed for skin cancer recurrence at the previously treated site.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Lesions Analyzed', 'denomUnitsSelected': 'Lesions Analyzed'}, {'type': 'SECONDARY', 'title': 'Comparison of Late Toxicities Related to eBx vs. Mohs Treatment Using A Chronic Toxicity Questionnaire Based on Physician Assessment at Long-term Prospective Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'OG000'}, {'value': '181', 'groupId': 'OG001'}]}, {'units': 'Lesions Analyzed', 'counts': [{'value': '208', 'groupId': 'OG000'}, {'value': '208', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Electronic Brachytherapy', 'description': 'Previously completed treatment of 1 or more lesions per participant for non-melanoma skin cancer'}, {'id': 'OG001', 'title': 'Mohs Surgery', 'description': 'Previously completed treatment of 1 or more lesions per participant for non-melanoma skin cancer'}], 'classes': [{'categories': [{'measurements': [{'value': '138', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Range greater or equal to 3 years post last Xoft eBx or MMS treatment at the time of study start at1 long-term prospective visit by study completion.', 'description': 'Subjects treated with Xoft eBx or MMS over 3 years prior were called in for a long-term prospective visit, consented, and assessed to determine if late toxicities occurred at the previously treated site with Xoft eBx or MMS.', 'unitOfMeasure': 'lesions', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Lesions Analyzed', 'denomUnitsSelected': 'Lesions Analyzed'}, {'type': 'SECONDARY', 'title': 'Comparison of Long-term Cosmetic Outcomes for Lesions Treated for NMSC With eBx vs. Mohs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'OG000'}, {'value': '181', 'groupId': 'OG001'}]}, {'units': 'Lesions Analyzed', 'counts': [{'value': '208', 'groupId': 'OG000'}, {'value': '208', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Electronic Brachytherapy', 'description': 'Previously completed treatment of 1 or more lesions per participant for non-melanoma skin cancer'}, {'id': 'OG001', 'title': 'Mohs Surgery', 'description': 'Previously completed treatment of 1 or more lesions per participant for non-melanoma skin cancer'}], 'classes': [{'categories': [{'measurements': [{'value': '203', 'groupId': 'OG000'}, {'value': '199', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Range greater or equal to 3 years post last Xoft eBx or MMS treatment at the time of study start at1 long-term prospective visit by study completion.', 'description': 'Subjects treated with Xoft eBx or MMS over 3 years prior were called in for a long-term prospective visit, consented, and an assessment of cosmetic outcome occurred at the previously treated site with Xoft eBx or MMS.', 'unitOfMeasure': 'lesions', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Lesions Analyzed', 'denomUnitsSelected': 'Lesions Analyzed'}, {'type': 'SECONDARY', 'title': 'Chronic Toxicities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'OG000'}, {'value': '181', 'groupId': 'OG001'}]}, {'units': 'Lesions Analyzed', 'counts': [{'value': '208', 'groupId': 'OG000'}, {'value': '208', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Electronic Brachytherapy', 'description': 'Previously completed treatment of 1 or more lesions per participant for non-melanoma skin cancer'}, {'id': 'OG001', 'title': 'Mohs Surgery', 'description': 'Previously completed treatment of 1 or more lesions per participant for non-melanoma skin cancer'}], 'classes': [{'categories': [{'measurements': [{'value': '138', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'Range greater or equal to 3 years post last Xoft eBx or MMS treatment at the time of study start at1 long-term prospective visit by study completion.', 'description': 'Subjects treated with Xoft eBx or MMS over 3 years prior were called in for a long-term prospective visit, consented, and assessed to determine if there were any chronic toxicities found at the previously treated site with Xoft eBx or MMS.', 'unitOfMeasure': 'Lesions Analyzed', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Lesions Analyzed', 'denomUnitsSelected': 'Lesions Analyzed', 'populationDescription': 'Analysis same as late toxicities.'}, {'type': 'SECONDARY', 'title': 'Patient Survey for Reporting Patient Reported Outcomes (PRO)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'OG000'}, {'value': '181', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Electronic Brachytherapy', 'description': 'Previously completed treatment of 1 or more lesions per participant for non-melanoma skin cancer'}, {'id': 'OG001', 'title': 'Mohs Surgery', 'description': 'Previously completed treatment of 1 or more lesions per participant for non-melanoma skin cancer'}], 'classes': [{'categories': [{'measurements': [{'value': '54.0', 'spread': '9.0', 'groupId': 'OG000'}, {'value': '56.0', 'spread': '5.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Range greater or equal to 3 years post last Xoft eBx or MMS treatment at the time of study start, with 1 long-term prospective visit by study completion.', 'description': 'Subjects treated with Xoft eBx or MMS over 3 years prior were called in for a long-term prospective visit, consented, then subjects completed a Patient Satisfaction Score: min=0, max=60, with 60 as the maximum positive or favorable response.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Mohs Surgery', 'description': 'Previously completed treatment for non-melanoma skin cancer using Mohs Surgery'}, {'id': 'FG001', 'title': 'Electronic Brachytherapy', 'description': 'Previously completed treatment for non-melanoma skin cancer using Xoft eBx Electronic Brachytherapy System'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': "Patient's return for follow-up visit to asses long-term outcomes of previous treatment with Mohs.", 'groupId': 'FG000', 'numSubjects': '181'}, {'comment': "Patient's return for follow-up visit to asses long-term outcomes of previous treatment with eBx.", 'groupId': 'FG001', 'numSubjects': '188'}]}, {'type': 'Completed Enrollment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '181'}, {'groupId': 'FG001', 'numSubjects': '188'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '181'}, {'groupId': 'FG001', 'numSubjects': '188'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Identify and collect any existing data from the patients record and conduct office visits on patients with non-melanoma skin cancer who underwent treatment with either eBx or Mohs and completed treatment approximately 3 yrs prior (range of 2-4 years) to asses long-term outcomes of treated areas.', 'preAssignmentDetails': 'N/A This is a retrospective-prospective study design.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'BG000'}, {'value': '181', 'groupId': 'BG001'}, {'value': '369', 'groupId': 'BG002'}]}, {'units': 'Lesions Analyzed', 'counts': [{'value': '208', 'groupId': 'BG000'}, {'value': '208', 'groupId': 'BG001'}, {'value': '416', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Electronic Brachytherapy', 'description': 'Previously completed treatment of 1 or more non-melanoma skin cancer lesions per participant using Xoft eBx Electronic Brachytherapy System'}, {'id': 'BG001', 'title': 'Mohs Surgery', 'description': 'Previously completed treatment of 1 or more lesions per participant for non-melanoma skin cancer using Mohs Surgery'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'eBx', 'categories': [{'measurements': [{'value': '80.8', 'spread': '7.2', 'groupId': 'BG000'}, {'value': '76.6', 'spread': '8.8', 'groupId': 'BG001'}, {'value': '78.7', 'spread': '8.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'denomUnitsSelected': 'Participants'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Female', 'categories': [{'measurements': [{'value': '65', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '126', 'groupId': 'BG002'}]}]}, {'title': 'Male', 'categories': [{'measurements': [{'value': '123', 'groupId': 'BG000'}, {'value': '120', 'groupId': 'BG001'}, {'value': '243', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'African American', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Caucasian Non-Hispanic', 'categories': [{'measurements': [{'value': '186', 'groupId': 'BG000'}, {'value': '180', 'groupId': 'BG001'}, {'value': '366', 'groupId': 'BG002'}]}]}, {'title': 'Asian Pacific Islander', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants'}, {'title': 'Lesions by Size', 'classes': [{'title': 'Lesions less than 1cm', 'categories': [{'measurements': [{'value': '57', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '114', 'groupId': 'BG002'}]}]}, {'title': 'Lesions greater than 1cm less than 2cm', 'categories': [{'measurements': [{'value': '146', 'groupId': 'BG000'}, {'value': '146', 'groupId': 'BG001'}, {'value': '292', 'groupId': 'BG002'}]}]}, {'title': 'Lesions greater than 2cm less than 3cm', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': '0 ≤1cm 0 \\>1cm and ≤2cm 0 \\>2cm and \\>2cm 0 N/A', 'unitOfMeasure': 'lesions', 'denomUnitsSelected': 'Lesions Analyzed'}], 'typeUnitsAnalyzed': 'Lesions Analyzed'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-03-07', 'size': 410821, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-12-09T09:18', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 369}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2017-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-04', 'studyFirstSubmitDate': '2017-01-11', 'resultsFirstSubmitDate': '2018-03-20', 'studyFirstSubmitQcDate': '2017-01-15', 'lastUpdatePostDateStruct': {'date': '2025-02-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-02-04', 'studyFirstPostDateStruct': {'date': '2017-01-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2025-02-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Absence of Local Recurrence at Treatment Site(s) Greater or Equal to 3 Years Follow-up', 'timeFrame': 'Range greater or equal to 3 years post last Xoft eBx or MMS treatment at the time of study start at1 long-term prospective visit by study completion.', 'description': 'Subjects treated with Xoft eBx or MMS over 3 years prior were called in for a long-term prospective visit, consented, and assessed for skin cancer recurrence at the previously treated site.'}], 'secondaryOutcomes': [{'measure': 'Comparison of Late Toxicities Related to eBx vs. Mohs Treatment Using A Chronic Toxicity Questionnaire Based on Physician Assessment at Long-term Prospective Visit', 'timeFrame': 'Range greater or equal to 3 years post last Xoft eBx or MMS treatment at the time of study start at1 long-term prospective visit by study completion.', 'description': 'Subjects treated with Xoft eBx or MMS over 3 years prior were called in for a long-term prospective visit, consented, and assessed to determine if late toxicities occurred at the previously treated site with Xoft eBx or MMS.'}, {'measure': 'Comparison of Long-term Cosmetic Outcomes for Lesions Treated for NMSC With eBx vs. Mohs', 'timeFrame': 'Range greater or equal to 3 years post last Xoft eBx or MMS treatment at the time of study start at1 long-term prospective visit by study completion.', 'description': 'Subjects treated with Xoft eBx or MMS over 3 years prior were called in for a long-term prospective visit, consented, and an assessment of cosmetic outcome occurred at the previously treated site with Xoft eBx or MMS.'}, {'measure': 'Chronic Toxicities', 'timeFrame': 'Range greater or equal to 3 years post last Xoft eBx or MMS treatment at the time of study start at1 long-term prospective visit by study completion.', 'description': 'Subjects treated with Xoft eBx or MMS over 3 years prior were called in for a long-term prospective visit, consented, and assessed to determine if there were any chronic toxicities found at the previously treated site with Xoft eBx or MMS.'}, {'measure': 'Patient Survey for Reporting Patient Reported Outcomes (PRO)', 'timeFrame': 'Range greater or equal to 3 years post last Xoft eBx or MMS treatment at the time of study start, with 1 long-term prospective visit by study completion.', 'description': 'Subjects treated with Xoft eBx or MMS over 3 years prior were called in for a long-term prospective visit, consented, then subjects completed a Patient Satisfaction Score: min=0, max=60, with 60 as the maximum positive or favorable response.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Nonmelanoma Skin Cancer']}, 'referencesModule': {'references': [{'pmid': '28951753', 'type': 'RESULT', 'citation': 'Patel R, Strimling R, Doggett S, Willoughby M, Miller K, Dardick L, Mafong E. Comparison of electronic brachytherapy and Mohs micrographic surgery for the treatment of early-stage non-melanoma skin cancer: a matched pair cohort study. J Contemp Brachytherapy. 2017 Aug;9(4):338-344. doi: 10.5114/jcb.2017.68480. Epub 2017 Jun 23.'}]}, 'descriptionModule': {'briefSummary': "This is a retrospective-prospective study design. Patients who completed treatment approximately 3 years (range of 2-4 years) at time of IRB approval of this study will be identified and any existing data in the patient's record will be collected in addition to conducting office visits for long-term follow-up.", 'detailedDescription': "This is a retrospective-prospective study design. Patients who completed treatment approximately 3 years (range of 2-4 years) at time of IRB approval of this study will be identified and any existing data in the patient's record will be collected in addition to conducting office visits for long-term follow-up. The study will include 2 parts:\n\n1. Retrospective chart review: Collect data from patient records who completed treatment a minimum of 2 years prior to study onset and determine the feasibility of doing a matched pair cohort study comparison of eBx versus Mohs surgery. The history, demographic and treatment data will be retrospectively collected from up to 320 subjects previously treated with eBx for the treatment of NMSC and up to 320 subjects previously treated with Mohs surgery for the treatment of NMSC.\n2. Prospective Follow-up: Patients will return for long-term follow-up visits for the investigators to assess the lesion site, document absence of recurrence/ absence of recurrence, toxicities, and collect patient reported outcomes."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '41 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Up to 320 subjects treated with eBx and up to 320 subjects treated with Mohs surgery will have data collected retrospectively from the patient's medical records, and prospectively at the time of the follow-up visit for those who agree to participate in this study.", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Previously completed treatment for non-melanoma skin cancer using Xoft eBx Electronic Brachytherapy System or Mohs surgery;\n2. Provides informed Consent;\n3. Greater than 40 years of age;\n4. Pathological diagnosis confirmed to be squamous cell or basal cell carcinoma prior to treatment;\n5. Cancer Staging included in this study:\n\n * Stage 0: Tis, N0, M0\n * Stage 1: T1, N0, M0\n * Stage 2: T2, N0, M0 and ≤ 4cm in diameter\n\nExclusion Criteria:\n\n1. Target area is adjacent to a burn scar\n2. Any prior definitive surgical resection of the cancer, prior to Radiation Treatment\n3. Known perineural invasion\n4. Actinic Keratosis\n5. Known spread to regional lymph nodes\n6. Known metastatic disease'}, 'identificationModule': {'nctId': 'NCT03024866', 'briefTitle': 'Comparison of eBX and Mohs Surgery for Treatment of Early-stage Non-melanoma Skin Cancer a Matched Pair Cohort Study.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Xoft, Inc.'}, 'officialTitle': 'A Multi-Center Retrospective-Prospective Matched Pairs Cohort Study to Assess Long-term Clinical Outcomes of Non-melanoma Skin Cancer Patients Treated With eBx Compared to Non-melanoma Skin Cancer Patients Treated With Mohs Surgery', 'orgStudyIdInfo': {'id': 'CTPR-0014'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Electronic Brachytherapy', 'description': 'Procedure/Surgery: Electronic Brachytherapy:\n\nPreviously completed treatment for non-melanoma skin cancer using Xoft eBx Electronic Brachytherapy System. High-dose-rate electronic brachytherapy (EBT) provides a non-surgical treatment option for non-melanoma skin cancer (NMSC).', 'interventionNames': ['Procedure: Electronic Brachytherapy']}, {'label': 'Mohs Surgery', 'description': 'Previously completed treatment for non-melanoma skin cancer using Mohs Surgery:\n\nUniquely orients, maps, and processes removed tissue, permitting the microscopic evaluation of virtually 100% of the specimen margins. The completeness of this margin control permits the accurate identification and removal of all tumor extensions under the microscope. Tissues in Mohs surgery are processed as modified frozen sections which allow the accurate and rapid interpretation of most skin cancers.', 'interventionNames': ['Procedure: Electronic Brachytherapy']}], 'interventions': [{'name': 'Electronic Brachytherapy', 'type': 'PROCEDURE', 'otherNames': ['Mohs Surgery'], 'description': 'A group receives High-dose-rate electronic brachytherapy (EBT) which provides a non-surgical treatment option and the other group receives Mohs surgery. This matched-pair cohort study compared the outcomes of treatment with EBT to those of Mohs surgery in patients with NMSC.', 'armGroupLabels': ['Electronic Brachytherapy', 'Mohs Surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95032', 'city': 'Los Gatos', 'state': 'California', 'country': 'United States', 'facility': 'Kenneth A. Miller, PC', 'geoPoint': {'lat': 37.22661, 'lon': -121.97468}}, {'zip': '91910', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Dermatology & Laser Center of San Diego', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '92103', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Dermatology and Laser Center of San Diego', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '89144', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Strimling Laser and Vein Institute', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}], 'overallOfficials': [{'name': 'Rakesh Patel, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Good Samaritan Radiation Oncology'}, {'name': 'Robert Strimling', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Strimling Dermatology, Laser, and Vein Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xoft, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Eminence Clinical Research, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}