Ignite Creation Date:
2025-12-24 @ 4:46 PM
Ignite Modification Date:
2025-12-30 @ 2:56 AM
Study NCT ID:
NCT01077050
Status:
COMPLETED
Last Update Posted:
2013-12-30
First Post:
2010-02-25
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
SciBase International Melanoma Pivotal Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008545', 'term': 'Melanoma'}], 'ancestors': [{'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D018326', 'term': 'Nevi and Melanomas'}, {'id': 'D012878', 'term': 'Skin Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'per.svedenhag@scibase.se', 'phone': '+46841062001', 'title': 'Director of Clinical Operations', 'organization': 'SciBase'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'A post-procedure follow up, either by a telephone or investigational site visit, was to be conducted at 7 (seven) +/- 3 (three) days from the SciBase III evaluation, at which time the subject were to be evaluated for any adverse events.', 'description': "The Safety analysis population includes all subjects for whom there was any contact with subject's skin and the SciBase III investigational device. Therefore the number of subjects included in the safety analysis deviates from both the total number of enrolled and eligible subjects.", 'eventGroups': [{'id': 'EG000', 'title': 'Biopsied Skin Lesions', 'description': "Any adverse advent that occured on a skin/lesion site for whom there had been any contact between the subject's skin and investigational device (SciBase III).\n\nNote that multiple adverse event occured on some subjects. In total 36 Adverse Events were reported on 28 subjects.", 'otherNumAtRisk': 1915, 'otherNumAffected': 28, 'seriousNumAtRisk': 1915, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Experienced bleeding through the bandage after excision.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1915, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Experienced a headache/migrane post SciBase measurements and surgical excision.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1915, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Lesion started to bleed during examination/measurement', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1915, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Experience of slight pain from excision', 'notes': 'Experienced pain from the wound or excisional site.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1915, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Experience of slight pain/pin pricks from probe', 'notes': 'Experienced slight pain / pin pricks from the probe. Resolved once the probe was removed or measurements ended.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1915, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Experience of soreness/itch/tingling at excisional/measurement site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1915, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Developed infection following excision', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1915, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Suffered from a cold', 'notes': 'Suffered from a cold for 3 days after the excision had been performed.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1915, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Neck and facial swelling after lymph node dissection', 'notes': 'Suffered from neck and facial swelling 2 days after lymph node dissection surgery had been performed.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1915, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Experience nausea', 'notes': 'Experience nausea for 2 days post measurement and excision', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1915, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Suffered from diarrhea', 'notes': 'Suffered from diarrhea for two days after measurements and excision', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1915, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Suture came out prematurely', 'notes': 'One suture came out prematurely.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1915, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Minimal brusing', 'notes': 'Experienced very minimal bruising appeared on the measurement site approximately 10 minutes after four attempts had been made to obtain a device reading.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1915, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Experienced sensation of fainting', 'notes': 'Became pale and felt faint immediately following the biopsy. The subject felt much better after lying down and was able to leave the clinic under his own power.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1915, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Experienced mild chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1915, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'SciBase Sensitivity and Specificity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1611', 'groupId': 'OG000'}]}, {'units': 'Biopsied Skin Lesions', 'counts': [{'value': '1943', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Biopsied Skin Lesions', 'description': 'Lesions for which clinical management was prospectively determined to be biopsy of the lesion in toto'}], 'classes': [{'title': 'SciBase Sensitivity to melanoma', 'categories': [{'measurements': [{'value': '96.6', 'groupId': 'OG000', 'lowerLimit': '93.7', 'upperLimit': '98.4'}]}]}, {'title': 'SciBase Specificity to non-melanoma', 'categories': [{'measurements': [{'value': '31.4', 'groupId': 'OG000', 'lowerLimit': '29.2', 'upperLimit': '33.7'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Sensitivity to Melanoma', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '95', 'paramValue': '96.6', 'ciLowerLimit': '94.2', 'pValueComment': 'The point estimate of the observed sensitivity that is based on generalized linear mixed model is equal to that calculated in the usual manner.', 'statisticalMethod': 'Clopper-Pearson 1-sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000'], 'paramType': 'Sensitivity to Basal Cell Carcinoma', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '100', 'ciLowerLimit': '92.6', 'ciUpperLimit': '100', 'statisticalMethod': 'Clopper-Pearson 2-sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Point estimate of the observed sensitivity for Basal Cell Carcinoma', 'testedNonInferiority': False}, {'groupIds': ['OG000'], 'paramType': 'Observed sensitivity for squamous cell c', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '93.3', 'ciLowerLimit': '68.1', 'ciUpperLimit': '99.8', 'statisticalMethod': 'Clopper-Pearson 2-sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Point estimate of the observed sensitivity for squamous cell carcinoma', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '13.0', 'ciLowerLimit': '6.6', 'ciUpperLimit': '25.5', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Note that calculating odds ratio adjusting for subjects having multiple lesions, yields similar result.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Post data lock', 'description': 'This study has two co-primary objectives, aiming to demonstrate the accuracy of SciBase device:\n\n1. Sensitivity ≥ 0.90 to detect Melanoma\n2. Sensitivity - (1-Specificity) \\> 0.00\n\nSensitivity is the proportion of correctly identified cases of Melanoma. Specificity is the proportion of correctly identified cases of non-melanoma.', 'unitOfMeasure': 'Percentage of total lesions', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Biopsied Skin Lesions', 'denomUnitsSelected': 'Participants', 'populationDescription': 'Biopsied Skin Lesions'}, {'type': 'SECONDARY', 'title': 'Sensitivity and Specificity', 'timeFrame': 'Post data lock', 'description': 'Secondary confirmatory objective included two co-secondary endpoints that were defined similarly to the co-primary endpoints, but used the Secondary definition of dichotomous reference diagnosis.\n\nPositive Reference Diagnosis: Melanoma, Squamous Cell Carcinoma, Basal Cell Carcinoma, Severe Dysplastic Nevus (High grade dysplasia)\n\nNegative Reference Diagnosis: All other skin lesions.', 'reportingStatus': 'NOT_POSTED', 'anticipatedPostingDate': '2013-08'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Only One Arm in the Study, Thus Not Applicable.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1951'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1942'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}]}], 'dropWithdraws': [{'type': 'Subjects signed ICF could not be located', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Screen failure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}]}]}], 'recruitmentDetails': 'Recruitment was conducted at five (5) US investigational sites and at seventeen (17) European investigational sites.\n\nRecruitment period 2010-2011. In 2012 the last histological analysis was performed.', 'preAssignmentDetails': 'Potential study subjects were screened according to the inclusion/exclusion criteria. All study eligible skin lesion(s) were then examined with the investigational device, photographed and removed by an excisional biopsy.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1942', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Biopsied Skin Lesions', 'description': 'Lesions for which clinical management was prospectively determined to be biopsy of the lesion in toto'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '1499', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '443', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '49.8', 'spread': '16.9', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1013', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '929', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '458', 'groupId': 'BG000'}]}]}, {'title': 'Europe', 'categories': [{'measurements': [{'value': '1484', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'All study eligible skin lesion(s) were examined with the investigational device, photographed and removed by an excisional biopsy.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1951}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'completionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-11-08', 'studyFirstSubmitDate': '2010-02-25', 'resultsFirstSubmitDate': '2013-06-12', 'studyFirstSubmitQcDate': '2010-02-25', 'lastUpdatePostDateStruct': {'date': '2013-12-30', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-11-08', 'studyFirstPostDateStruct': {'date': '2010-02-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-12-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'SciBase Sensitivity and Specificity', 'timeFrame': 'Post data lock', 'description': 'This study has two co-primary objectives, aiming to demonstrate the accuracy of SciBase device:\n\n1. Sensitivity ≥ 0.90 to detect Melanoma\n2. Sensitivity - (1-Specificity) \\> 0.00\n\nSensitivity is the proportion of correctly identified cases of Melanoma. Specificity is the proportion of correctly identified cases of non-melanoma.'}], 'secondaryOutcomes': [{'measure': 'Sensitivity and Specificity', 'timeFrame': 'Post data lock', 'description': 'Secondary confirmatory objective included two co-secondary endpoints that were defined similarly to the co-primary endpoints, but used the Secondary definition of dichotomous reference diagnosis.\n\nPositive Reference Diagnosis: Melanoma, Squamous Cell Carcinoma, Basal Cell Carcinoma, Severe Dysplastic Nevus (High grade dysplasia)\n\nNegative Reference Diagnosis: All other skin lesions.'}]}, 'conditionsModule': {'conditions': ['Malignant Melanoma']}, 'referencesModule': {'references': [{'pmid': '12877688', 'type': 'BACKGROUND', 'citation': 'Aberg P, Nicander I, Holmgren U, Geladi P, Ollmar S. Assessment of skin lesions and skin cancer using simple electrical impedance indices. Skin Res Technol. 2003 Aug;9(3):257-61. doi: 10.1034/j.1600-0846.2003.00017.x.'}, {'pmid': '15605856', 'type': 'BACKGROUND', 'citation': 'Aberg P, Nicander I, Hansson J, Geladi P, Holmgren U, Ollmar S. Skin cancer identification using multifrequency electrical impedance--a potential screening tool. IEEE Trans Biomed Eng. 2004 Dec;51(12):2097-102. doi: 10.1109/TBME.2004.836523.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this clinical investigation was to determine the safety and effectiveness of the SciBase III device (Test) designed to help distinguish between malignant melanoma and benign lesions, using electrical impedance spectroscopy (EIS) relative to the histological gold standard (Reference).\n\nThe purpose of the study is to collect data to support a Pre-market Application(PMA) to obtain Food and Drug Administration(FDA) approval to market the SciBase III Electrical Impedance Spectrometer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria\n\nFor inclusion in the study, all subjects had to fulfill all of the following criteria:\n\n* Men or women of any ethnic group aged ≥18 years\n* Primary lesions (i.e., not metastases or recurrent lesions) that the physicians choose to excise.\n* Lesion ≥ 2 mm in diameter and ≤ 20 mm in diameter\n* In subjects with multiple skin lesions, all lesions destined for excision must be identified for purposes of study participation. Note: a subject may only be entered into the study once.\n* The subject is willing and able to read, understand and sign the study specific informed consent form.\n\nExclusion Criteria:\n\nSubjects were excluded from the study if they fulfilled any of the following criteria:\n\n* Skin surface not measurable, e.g. lesion on a stalk\n* Skin surface not accessible, e.g. inside ears, under nails\n* Lesion located on acral skin, e.g. sole or palms.\n* Lesion located on areas of scars, crusts, psoriasis, eczema or similar skin conditions.\n* Lesion on hair-covered areas, e.g. scalp, beards, moustaches or whiskers.\n* Lesion located on genitalia.\n* Lesion located in an area that has been previously biopsied or subjected to any kind of surgical intervention or traumatized.\n* Lesion located on mucosal surfaces.\n* Skin is not intact (measurement area) e.g. bleeding or with clinical noticeable ulceration.\n* Lesion with foreign matter, e.g. tattoo, splinter\n* Lesion and/or reference located on acute sunburn.'}, 'identificationModule': {'nctId': 'NCT01077050', 'briefTitle': 'SciBase International Melanoma Pivotal Study', 'organization': {'class': 'OTHER', 'fullName': 'SciBase AB'}, 'officialTitle': 'SciBase International Melanoma Pivotal Study', 'orgStudyIdInfo': {'id': 'SIMPS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'SciBase III', 'description': 'Subjects with suspected malignant melanoma or lesions designated for total excision were included into the study. To ensure no selection bias, all eligible lesions from a subject were included into the study. All study eligible skin lesion(s) were examined with the investigational device, photographed and removed by an excisional biopsy.', 'interventionNames': ['Device: SciBase III Electrical Impedance Spectrometer']}], 'interventions': [{'name': 'SciBase III Electrical Impedance Spectrometer', 'type': 'DEVICE', 'description': 'SciBase III Electrical Impedance Spectrometer is based on Electrical Impedance Spectroscopy (EIS). EIS is a measure of the overall resistance within a skin tissue, at alternating currents of various frequencies. Enrolled subject will undergo skin measurements with SciBase III Electrical Impedance Spectrometer. The relevant skin lesion(s) will be excised and diagnosed as per routine treatment.', 'armGroupLabels': ['SciBase III']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85719', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'University of Arizona', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '41345', 'city': 'Gothenburg', 'country': 'Sweden', 'facility': 'Sahlgrenska University Hospital', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}], 'overallOfficials': [{'name': 'Ulrik H Birgersson, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'SciBase and Karolinska Institutet'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'SciBase AB', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}