Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2026-03-01 @ 4:13 PM
Study NCT ID:
NCT03228693
Status:
COMPLETED
Last Update Posted:
2023-03-29
First Post:
2017-07-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Gene Expression and Biomarker Profiling of Keloid Skin
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007627', 'term': 'Keloid'}], 'ancestors': [{'id': 'D003095', 'term': 'Collagen Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D002921', 'term': 'Cicatrix'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-09-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2023-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-28', 'studyFirstSubmitDate': '2017-07-20', 'studyFirstSubmitQcDate': '2017-07-21', 'lastUpdatePostDateStruct': {'date': '2023-03-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Keloid progression', 'timeFrame': 'One year', 'description': 'Assess effectiveness of triamcinolone injection (keloid size measured in millimeters)'}, {'measure': 'Gene Expression', 'timeFrame': 'One year', 'description': 'Blood will be drawn during first study visit for analysis'}, {'measure': 'Keloid recurrence', 'timeFrame': 'One year', 'description': 'Assess keloid recurrence at biopsy site (measured by number of keloids)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Keloid'], 'conditions': ['Keloid', 'Keloid of Ear Lobe', 'Healthy Adults']}, 'descriptionModule': {'briefSummary': "This study aims to examine both the genetic profile and the biomarkers implicated in keloid scar formation.\n\nHypothesis:\n\n1. Differences in the genetic profiles of lesional and non-lesional skin contribute a given population's propensity to develop keloids\n2. Differences in biomolecules expressed in subjects with and without keloids can help predict keloid occurrence and severity\n3. Biomarker analysis will provide useful insights for future targeted therapies for keloid scars", 'detailedDescription': 'Objectives:\n\n1. Determine gene expression profiles of keloid scar tissue using samples collected longitudinally\n2. Define and compare the molecular biomarkers of keloid scars in keloid (lesional) and non-lesional skin biopsies and serum samples from adult subjects'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient with an untreated keloid scar or a patient with a keloid scar that has not had treatment for at least 6 months before time of enrollment\n* Patients without keloids coming into the dermatology clinic for a keloid unrelated issue (Group 5 only)\n\nExclusion Criteria:\n\n* Patients who have had treatment of their keloid scar within 6 months of date of enrollment'}, 'identificationModule': {'nctId': 'NCT03228693', 'briefTitle': 'Gene Expression and Biomarker Profiling of Keloid Skin', 'organization': {'class': 'OTHER', 'fullName': 'Northwestern University'}, 'officialTitle': 'Gene Expression and Biomarker Profiling of Keloid Skin', 'orgStudyIdInfo': {'id': 'RVK 09062016'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group 1', 'description': 'Baseline lesional and non-lesional biopsies and re-biopsy 6-8 weeks later with intralesional triamcinolone injections at 9-10, 12-16, and 24-32 weeks.', 'interventionNames': ['Procedure: Biopsy and/or triamcinolone injection']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 2', 'description': 'Baseline lesional biopsy and re-biopsy at 6-8 weeks with intralesional triamcinolone injections at 3-4, 9-10, 12-16, and 24-32 weeks', 'interventionNames': ['Procedure: Biopsy and/or triamcinolone injection']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 3', 'description': 'Baseline lesional and non-lesional biopsy and re-biopsy 3-4 months later with intralesional triamcinolone injections at 18-20 and 24-32 weeks.', 'interventionNames': ['Procedure: Biopsy and/or triamcinolone injection']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 4', 'description': 'Baseline lesional biopsy and re-biopsy at 3-4 months with intralesional triamcinolone injections at 3-4, 6-8, 18-20 and 24-32 weeks.', 'interventionNames': ['Procedure: Biopsy and/or triamcinolone injection']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 5', 'description': 'Normal patient skin (surgical or adjacent to other biopsy) from subjects with no self-reported history of keloids.', 'interventionNames': ['Procedure: Biopsy and/or triamcinolone injection']}, {'type': 'OTHER', 'label': 'Earlobe Keloid', 'description': 'Complete excision of an earlobe keloid measuring \\> 10mm will be taken.', 'interventionNames': ['Procedure: Excisional Biopsy']}], 'interventions': [{'name': 'Biopsy and/or triamcinolone injection', 'type': 'PROCEDURE', 'description': 'Subjects will have their blood drawn during the first study visit. Subsequently, a punch biopsy and/or triamcinolone injection will be given based on group timeline.', 'armGroupLabels': ['Group 1', 'Group 2', 'Group 3', 'Group 4', 'Group 5']}, {'name': 'Excisional Biopsy', 'type': 'PROCEDURE', 'description': 'Complete excision of an earlobe keloid will be taken.', 'armGroupLabels': ['Earlobe Keloid']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University Feinberg School of Medicine Department of Dermatology', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Roopal Kundu, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Northwestern University Feinberg School of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northwestern University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Regeneron Pharmaceuticals', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Dermatology and Medical Education', 'investigatorFullName': 'Roopal Kundu', 'investigatorAffiliation': 'Northwestern University'}}}}