Ignite Creation Date:
2025-12-24 @ 7:52 PM
Ignite Modification Date:
2026-01-25 @ 8:02 AM
Study NCT ID:
NCT03464604
Status:
TERMINATED
Last Update Posted:
2022-11-23
First Post:
2018-02-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Melanoma Accuracy Study; Phase 2
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 121}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'COVID forced the termination of this study. No impact on participants already enrolled.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-02-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2018-10-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-18', 'studyFirstSubmitDate': '2018-02-27', 'studyFirstSubmitQcDate': '2018-03-07', 'lastUpdatePostDateStruct': {'date': '2022-11-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pre-screening lesions low to moderate risk for melanoma by a nurse, will facilitate a more timely diagnosis of melanoma.', 'timeFrame': '3 years', 'description': 'Pre-screening referrals to the Department of Dermatology by a qualified nurse for patients with lesions, low to moderate risk for melanoma, would facilitate a more timely diagnosis of melanoma, and appropriate triaging of benign lesions.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Melanoma']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the process, accuracy and patient outcomes of pre-screening dermatology referrals in a clinical setting by a qualified nurse. The long-range goal of the proposed program is to improve referral wait times for patients to see a dermatologist for lesions suspicious for melanoma in comparison to normal standards of care in NS. If effective, this screening program would decrease wait times for those patients with lesions suspicious for melanoma providing earlier diagnosis and expedited treatment, and potentially reducing mortality rates.', 'detailedDescription': 'The purpose of this study is to evaluate the process, accuracy and patient outcomes of pre-screening dermatology referrals in a clinical setting by a qualified nurse using a dermatoscope, triaging suspicious lesions vs. benign lesions. The long-range goal of the proposed program is to improve referral wait times for patients to see a dermatologist for lesions suspicious for melanoma in comparison to normal standards of care in NS. If effective, this screening program would decrease wait times for those patients with lesions suspicious for melanoma providing earlier diagnosis and expedited treatment, and potentially reducing mortality rates.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients are 18+ (male or female) referred to the Department of Dermatology at the NSHA for a suspicious pigmented lesion(s).', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* New referral from a general practitioner to a dermatologist\n* Males and females, over the age of 18 are eligible to participate\n* Written informed consent from the patient\n* Lesion or mole is new, changing color, growing rapidly or has a change in sensation\n* Willing to have the lesion excised if necessary per standard of care\n* Ability to complete the imaging procedure and willing to complete a basic history\n* Pigmented lesion considered low, moderate or high risk for melanoma by a general practitioner\n\nExclusion Criteria\n\n* Lesions which are not amenable\n* Participant unable to read, understand or sign consent\n* Participant under active care by a dermatologist\n* Lesion \\<2 mm or \\>15mm in diameter\n* Lesion located on areas of scars, crusts, psoriasis, eczema or similar skin conditions\n* Lesion on hair covered areas (e.g. scalp, beard, mustache) where hair cannot be removed\n* Lesions located on genitalia not accessible to equipment\n* Lesions located in an area that has previously biopsied or subjected to any kind of surgical or ablative procedure\n* Lesion with foreign matter, e.g. tattoo or splinter\n* Lesion and/or reference located on acute sunburn\n* Skin surface not measurable, e.g. lesion on a stalk\n* Skin surface not accessible, e.g. inside ears, ears, under nails\n* Skin not intact (measurement area), e.g. bleeding or with clinically noticeable ulceration\n* Lesions located within 1cm of the eye\n* Lesions light in pigment or thick and nodular\n* Participants not willing to have the lesion excised'}, 'identificationModule': {'nctId': 'NCT03464604', 'briefTitle': 'Melanoma Accuracy Study; Phase 2', 'organization': {'class': 'OTHER', 'fullName': 'Nova Scotia Health Authority'}, 'officialTitle': 'Melanoma Accuracy Study, Phase Two', 'orgStudyIdInfo': {'id': '1023029'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1 Control group', 'description': 'Patients randomized into this group will follow normal standard of care in Nova Scotia'}, {'label': 'Group 2 Active group', 'description': 'Patients randomized into this group will be part of the active arm of the study. They will be pre-screened and asked the following questions:\n\n1. Sign an Information and Authorization form\n2. Demographic data: gender, date of birth, ethnicity\n3. Health history (duration of lesion, changes in lesion, specific changes, who identified the lesion, measurement in two greatest dimensions radially and color.', 'interventionNames': ['Diagnostic Test: active']}], 'interventions': [{'name': 'active', 'type': 'DIAGNOSTIC_TEST', 'description': 'Pre-screening for melanoma by qualified nurse', 'armGroupLabels': ['Group 2 Active group']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'B3A 4A7', 'city': 'Halifax', 'state': 'Nova Scotia', 'country': 'Canada', 'facility': 'Nova Scotia Health', 'geoPoint': {'lat': 44.64269, 'lon': -63.57688}}, {'zip': 'B3H 4A7', 'city': 'Halifax', 'state': 'Nova Scotia', 'country': 'Canada', 'facility': 'Nova Scotia Health', 'geoPoint': {'lat': 44.64269, 'lon': -63.57688}}], 'overallOfficials': [{'name': 'Richard G Lngley, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nova Scotia Health Authority'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nova Scotia Health Authority', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}