Ignite Creation Date:
2025-12-24 @ 2:55 PM
Ignite Modification Date:
2026-02-20 @ 6:25 PM
Study NCT ID:
NCT05418959
Status:
UNKNOWN
Last Update Posted:
2022-06-14
First Post:
2022-06-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Genetic Risk Stratification of Pediatric Skin Lesions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009506', 'term': 'Nevus'}], 'ancestors': [{'id': 'D018326', 'term': 'Nevi and Melanomas'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Non-invasive adhesive biopsies of suspicious skin lesions.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2024-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-06-13', 'studyFirstSubmitDate': '2022-06-09', 'studyFirstSubmitQcDate': '2022-06-13', 'lastUpdatePostDateStruct': {'date': '2022-06-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Presence or absence of PRAME genetic marker.', 'timeFrame': '1 day', 'description': 'Presence or absence of PRAME genetic marker from PLA test'}, {'measure': 'Presence or absence of LINC genetic marker.', 'timeFrame': '1 da7', 'description': 'Presence or absence of LINC genetic marker from PLA test'}], 'secondaryOutcomes': [{'measure': 'Incidence of Treatment-Emergent Adverse Events', 'timeFrame': '1 day', 'description': 'No. of adverse events from adhesive skin biopsy.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Skin Lesion', 'Nevus']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Jansen, B., Dobak, J. (2019) The Pigmented Lesion Assay Breakthrough: Enhanced Early Melanoma Detection with a Non-Invasive Gene Expression Test. DermTech, Inc. retrieved 4/11/20 from: https://dermtech.com/wp-content/uploads/PLA-TA.pdf'}, {'pmid': '32550693', 'type': 'BACKGROUND', 'citation': 'Brouha B, Ferris LK, Skelsey MK, Peck G, Moy R, Yao Z, Jansen B. Real-World Utility of a Non-Invasive Gene Expression Test to Rule Out Primary Cutaneous Melanoma: A Large US Registry Study. J Drugs Dermatol. 2020 Mar 1;19(3):257-262. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'A study to understand the clinical utility of noninvasive adhesive skin biopsies in pediatric patients by exploring whether DermTech Pigmented Lesion Assay (PLA) genetic risk analysis of suspicious lesions in children correlates with histopathological diagnosis.', 'detailedDescription': 'Patients (20 years of age or younger) with one or more atypical skin lesions requiring surgical biopsy within the next 6 months will be enrolled in the study. Prior to surgical biopsy, a DermTech PLA noninvasive adhesive will be performed on the lesion. The results of DermTech PLA genetic analysis will be compared to the results of histopathological diagnosis from surgical biopsy. Incidents of adverse events will also be collected.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '20 Years', 'minimumAge': '0 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 20 years of age or younger.\n* Subjects or parents willing and able to give informed consent, and assent as appropriate\n* Patients will have one or more atypical skin lesions with management plan of monitoring, surgical biopsy, and/or excision of atypical nevi within the next 6 months\n\nExclusion Criteria:\n\n* Lesions on palms, soles, mucosal membranes, or area where hair cannot be trimmed\n* Bleeding or ulcerated lesions\n* Previously biopsied, scarred, or known melanoma lesions\n* Presence of active psoriasis/eczema/other skin condition in area to be biopsied'}, 'identificationModule': {'nctId': 'NCT05418959', 'briefTitle': 'Genetic Risk Stratification of Pediatric Skin Lesions', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'Genetic Risk Stratification of Pediatric Skin Lesions', 'orgStudyIdInfo': {'id': '2022P001412'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DermTech PLA noninvasive adhesive biopsy', 'description': 'Prior to surgical biopsy, a DermTech PLA noninvasive adhesive will be pressed over the lesion to collect superficial skin cells.', 'interventionNames': ['Diagnostic Test: DermTech PLA noninvasive adhesive biopsy']}], 'interventions': [{'name': 'DermTech PLA noninvasive adhesive biopsy', 'type': 'DIAGNOSTIC_TEST', 'description': 'The clinician will firmly press the DermTech noninvasive adhesive on the lesion and use their thumb to make five circular motions on the lesion. The adhesive patch will then be pulled off of the area. This will be repeated for an additional three patches.', 'armGroupLabels': ['DermTech PLA noninvasive adhesive biopsy']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Elena B Hawryluk, MD, PhD', 'role': 'CONTACT', 'email': 'ehawryluk@partners.org', 'phone': '617-726-5066'}], 'overallOfficials': [{'name': 'Elena B Hawryluk, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Elena Hawryluk', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}