Ignite Creation Date:
2025-12-24 @ 1:59 PM
Ignite Modification Date:
2026-01-23 @ 5:49 AM
Study NCT ID:
NCT03699995
Status:
RECRUITING
Last Update Posted:
2025-06-05
First Post:
2018-10-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MoleMapper, Visiomed, and Confocal Microscopy in Screening Participants for Melanoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008545', 'term': 'Melanoma'}, {'id': 'D009508', 'term': 'Nevus, Pigmented'}], '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'}, {'id': 'D009506', 'term': 'Nevus'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D018613', 'term': 'Microscopy, Confocal'}, {'id': 'D046169', 'term': 'Dermoscopy'}, {'id': 'D014965', 'term': 'X-Rays'}, {'id': 'D008012', 'term': 'Lidocaine'}], 'ancestors': [{'id': 'D008853', 'term': 'Microscopy'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D000069416', 'term': 'Intravital Microscopy'}, {'id': 'D060733', 'term': 'Electromagnetic Radiation'}, {'id': 'D055590', 'term': 'Electromagnetic Phenomena'}, {'id': 'D060328', 'term': 'Magnetic Phenomena'}, {'id': 'D055585', 'term': 'Physical Phenomena'}, {'id': 'D011827', 'term': 'Radiation'}, {'id': 'D011839', 'term': 'Radiation, Ionizing'}, {'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-05-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-04', 'studyFirstSubmitDate': '2018-10-05', 'studyFirstSubmitQcDate': '2018-10-08', 'lastUpdatePostDateStruct': {'date': '2025-06-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Improvements in virtual triage of patients when enabling patients to take and submit digital dermoscopy images from home', 'timeFrame': 'Up to 1 year'}], 'primaryOutcomes': [{'measure': 'Sensitivity of the imaging modalities', 'timeFrame': 'Up to 1 year', 'description': 'Sensitivity is defined as recommend immediate biopsy (red) lesions correctly identified as red by the dermatologists. The nature of statistical data analyses will be descriptive and exploratory to estimate effect sizes and their variation as well as generate hypotheses for the future study design. Sensitivity and specificity will be estimated along with exact 95% confidence intervals.'}, {'measure': 'Specificity of imaging modalities', 'timeFrame': 'Up to 1 year', 'description': 'Specificity is defined as green (follow-up at annual skin exam) or yellow lesions (recommend examination by dermatologist in 3 months) correctly identified. The nature of statistical data analyses will be descriptive and exploratory to estimate effect sizes and their variation as well as generate hypotheses for the future study design. Sensitivity and specificity will be estimated along with exact 95% confidence intervals.'}], 'secondaryOutcomes': [{'measure': 'Sensitivity by changes after consideration of in vivo reflectance mode confocal scanning laser microscopy (RCM) report', 'timeFrame': 'Up to 1 year', 'description': 'Secondary analysis will be done with the biopsied lesions that were analyzed by RCM. The dermatologists will be provided a report of the RCM findings as well as the VisioMed images and asked to make the same classification as above. Changes in sensitivity and specificity will be determined.'}, {'measure': 'Specificity by changes after consideration of RCM report', 'timeFrame': 'Up to 1 year', 'description': 'Secondary analysis will be done with the biopsied lesions that were analyzed by RCM. The dermatologists will be provided a report of the RCM findings as well as the Visiomed images and asked to make the same classification as above. Changes in sensitivity and specificity will be determined.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cutaneous Melanoma', 'Melanocytic Nevus', 'Skin Carcinoma']}, 'descriptionModule': {'briefSummary': "This trial studies how well MoleMapper, Visiomed, and confocal microscopy work in screening participants for melanoma. Analyzing images (photographs) made with three different portable imaging systems may be as good as a visit to a dermatologist's office for finding melanomas before they can spread.", 'detailedDescription': 'PRIMARY OBJECTIVE:\n\nI. To assess the clinical utility of clinical images, digital dermoscopy images and in-vivo confocal microscopy for teledermatology.\n\nSECONDARY OBJECTIVE:\n\nI. To incorporate in vivo confocal images into the triage system in order to determine to what degree the information gathered in this modality changes the classification of a lesion assigned by a licensed dermatologist.\n\nTERTIARY OBJECTIVE:\n\nI. To assess the potential improvement of virtual patient triage when adding digital dermoscopy images to clinical images presented by patients to their provider (via e-visit or e-consult).\n\nOUTLINE:\n\nParticipants undergo imaging of suspicious moles via smartphone application (app) MoleMapper/Sklip app/native smartphone camera app, digital dermoscopy, and confocal microscopy. Participants then receive lidocaine subcutaneously (SC) and undergo shave or punch biopsy of suspected melanomas.\n\nAfter completion of study intervention, patients are followed up within 1 week.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Persons who participate in the free skin cancer screening at the PDX Skincare Festival at Oregon Health \\& Science University (OHSU) in 2021/2022 (date pending) and are informed by a provider that they have a pigmented lesion for which a biopsy is recommended are potentially eligible to participate in this study.\n* Persons who participate in the free skin cancer screening at the War on Skin Cancer event at OHSU in 2021/2022 (date pending) or other dates and locations and are informed by a provider that they have a clinically benign or atypical nevi are eligible to participate in the imaging portion of this study. No biopsy will be offered to these participants.\n* Persons age 18-80 are eligible for the study\n* Persons of any sex can be enrolled.\n* Persons of any race are eligible but we anticipate that most participants will be Non-Hispanic whites due to the prevalence of melanoma and other skin cancers in this group.\n* Only persons who can provide signed statement of informed consent will be enrolled.\n* Persons who are identified in OHSU Dermatology clinics or through OHSU e-visit and e-consult platforms as having a skin lesion in need of a biopsy for skin cancer\n* Persons identified via the Melanoma Community Registry (MCR) (IRB approved: 00010561)\n\nExclusion Criteria:\n\n* Allergy to the anesthetic (lidocaine).'}, 'identificationModule': {'nctId': 'NCT03699995', 'briefTitle': 'MoleMapper, Visiomed, and Confocal Microscopy in Screening Participants for Melanoma', 'organization': {'class': 'OTHER', 'fullName': 'OHSU Knight Cancer Institute'}, 'officialTitle': 'Imaging Modalities for Melanoma Screening and Diagnosis', 'orgStudyIdInfo': {'id': 'STUDY00018408'}, 'secondaryIdInfos': [{'id': 'NCI-2018-01152', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'STUDY00018408', 'type': 'OTHER', 'domain': 'OHSU Knight Cancer Institute'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Screening (imaging, biopsy)', 'description': 'Participants undergo imaging of suspicious moles via smartphone app MoleMapper/Sklip app/native smartphone camera app, digital dermoscopy, and confocal microscopy. Participants then receive lidocaine SC and undergo shave or punch biopsy of suspected melanomas.', 'interventionNames': ['Other: Confocal Microscopy', 'Other: Dermoscopy', 'Procedure: Imaging Procedure', 'Drug: Lidocaine', 'Procedure: Punch Biopsy', 'Procedure: Shave Biopsy']}], 'interventions': [{'name': 'Confocal Microscopy', 'type': 'OTHER', 'otherNames': ['Confocal Laser Scanning Microscopy'], 'description': 'Undergo confocal microscopy', 'armGroupLabels': ['Screening (imaging, biopsy)']}, {'name': 'Dermoscopy', 'type': 'OTHER', 'description': 'Undergo digital dermoscopy', 'armGroupLabels': ['Screening (imaging, biopsy)']}, {'name': 'Imaging Procedure', 'type': 'PROCEDURE', 'otherNames': ['Diagnostic Imaging Technique', 'Imaging', 'Imaging Procedures', 'Imaging Technique', 'imaging type', 'imaging_type', 'Medical Imaging'], 'description': 'Undergo MoleMapper/Sklip app/native smartphone camera app imaging with smartphone', 'armGroupLabels': ['Screening (imaging, biopsy)']}, {'name': 'Lidocaine', 'type': 'DRUG', 'otherNames': ['.omega.-Diethylamino-2,6-dimethylacetanilide', "2-(Diethylamino)-2',6'-acetoxylidide", 'Cuivasil', 'Duncaine', 'Leostesin', 'Lidothesin', 'Lignocaine', 'Rucaina'], 'description': 'Given SC', 'armGroupLabels': ['Screening (imaging, biopsy)']}, {'name': 'Punch Biopsy', 'type': 'PROCEDURE', 'otherNames': ['Punch Biopsy of Skin'], 'description': 'Undergo punch biopsy', 'armGroupLabels': ['Screening (imaging, biopsy)']}, {'name': 'Shave Biopsy', 'type': 'PROCEDURE', 'description': 'Undergo shave biopsy', 'armGroupLabels': ['Screening (imaging, biopsy)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Sancy Leachman, MD, PhD', 'role': 'CONTACT', 'email': 'leachmas@ohsu.edu', 'phone': '503-494-4713'}, {'name': 'Khoa Nguyen', 'role': 'CONTACT', 'email': 'nguyekho@ohsu.edu'}, {'name': 'Sancy Leachman, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Sancy Leachman', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}], 'centralContacts': [{'name': 'Sancy Leachman, MD, PhD', 'role': 'CONTACT', 'email': 'leachmas@ohsu.edu', 'phone': '503-494-4713'}], 'overallOfficials': [{'name': 'Joanna Ludzik, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'OHSU Knight Cancer Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'OHSU Knight Cancer Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'Oregon Health and Science University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Sancy A Leachman, MD, PhD', 'investigatorAffiliation': 'OHSU Knight Cancer Institute'}}}}