Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2026-03-08 @ 1:53 AM
Study NCT ID:
NCT01820234
Status:
COMPLETED
Last Update Posted:
2017-07-19
First Post:
2011-02-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Store-and-Forward Teledermatology Versus a Face-to-Face Assessment During a Skin Cancer Screening Event
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012878', 'term': 'Skin Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 170}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-03', 'completionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-17', 'studyFirstSubmitDate': '2011-02-04', 'studyFirstSubmitQcDate': '2013-03-25', 'lastUpdatePostDateStruct': {'date': '2017-07-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-03-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Aggregated diagnostic concordance', 'timeFrame': 'At the time of dermatologist evaluation (Day 1)', 'description': "Aggregated diagnostic concordance which is defined as the agreement of the in-person dermatologist's principle diagnosis with the teledermatologist's primary diagnosis or any of the differential diagnoses."}], 'secondaryOutcomes': [{'measure': 'Primary diagnostic concordance', 'timeFrame': 'At the time of dermatologist evaluation (Day 1)', 'description': 'Diagnostic concordance between the in-person dermatologist and the teledermatologist for their primary diagnosis.'}, {'measure': 'Categorical diagnostic concordance', 'timeFrame': 'At the time of dermatologist evaluation (Day 1)', 'description': 'Diagnostic concordance between the in-person dermatologist and teledermatologist based on standard clinical diagnostic categories for each lesion.'}, {'measure': 'Management concordance', 'timeFrame': 'At the time of dermatologist evaluation (Day 1)', 'description': 'The concordance between the in-person dermatologist and teledermatologist for the chosen management plan for each lesion.'}, {'measure': 'Sensitivity', 'timeFrame': 'At the time of dermatologist evaluation (Day 1)', 'description': 'The sensitivity of store-and-forward evaluation to detecting lesions that are either premalignant or malignant.'}, {'measure': 'Specificity', 'timeFrame': 'At the time of dermatologist evaluation (Day 1)', 'description': 'The specificity of store-and-forward evaluation to detecting lesions that are either premalignant or malignant.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Skin cancer', 'Teledermatology', 'Screening', 'Store-and-forward'], 'conditions': ['Skin Cancer', 'Screening', 'Telemedicine']}, 'descriptionModule': {'briefSummary': "The purpose of this study is to determine the diagnostic and management concordance of face-to-face dermatologist versus a store-and-forward teledermatologist at a skin cancer screening event.\n\nThe investigators' hypotheses include the following:\n\n1. Compared to in-person assessment, store-and-forward teledermatology assessment will result in adequate diagnostic concordance.\n2. Compared to in-person assessment, store-and-forward teledermatology results in adequate management concordance.\n3. The sensitivity and specificity of store-and-forward evaluation to detecting lesions that are either premalignant or malignant will be similar to that of in-person evaluation."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age or older at time of consent, may be male or female.\n* Able to provide a brief medical history and have/allow an examination of their skin including photographs.\n* Capable of giving informed consent.\n* Will be able to receive notification of follow-up recommendations\n\nExclusion Criteria:\n\n* Patients who will not provide informed consent\n* Patient who are unable to fulfill tasks of this study'}, 'identificationModule': {'nctId': 'NCT01820234', 'briefTitle': 'Evaluation of Store-and-Forward Teledermatology Versus a Face-to-Face Assessment During a Skin Cancer Screening Event', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Davis'}, 'officialTitle': 'Evaluation of Store-and-Forward Teledermatology Versus a Face-to-Face Assessment During a Skin Cancer Screening Event', 'orgStudyIdInfo': {'id': '201018315'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'In-person dermatology evaluation', 'description': 'Health care modality', 'interventionNames': ['Other: In-person dermatology evaluation']}, {'type': 'OTHER', 'label': 'Store-and-forward teledermatology evaluation', 'description': 'Health care modality', 'interventionNames': ['Other: Store-and-forward teledermatology evaluation']}], 'interventions': [{'name': 'In-person dermatology evaluation', 'type': 'OTHER', 'description': 'Every patient will be evaluated by an in person dermatologist present at the screening.', 'armGroupLabels': ['In-person dermatology evaluation']}, {'name': 'Store-and-forward teledermatology evaluation', 'type': 'OTHER', 'otherNames': ['Health care modality'], 'description': 'Every patient will be evaluated online via a store and forward teledermatology modality.', 'armGroupLabels': ['Store-and-forward teledermatology evaluation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95818', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'University of California, Davis Shifa Community Clinic', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}], 'overallOfficials': [{'name': 'April W Armstrong, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, Davis'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Davis', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}