Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 10:40 PM
Study NCT ID:
NCT01510067
Status:
RECRUITING
Last Update Posted:
2025-03-13
First Post:
2012-01-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prevalence and Clinical Severity of Cutaneous Lupus Erythematosus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008178', 'term': 'Lupus Erythematosus, Cutaneous'}], 'ancestors': [{'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood, Skin Tissue Biopsies'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 700}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2006-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2030-01-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-12', 'studyFirstSubmitDate': '2012-01-10', 'studyFirstSubmitQcDate': '2012-01-12', 'lastUpdatePostDateStruct': {'date': '2025-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-01-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2030-01-02', 'type': 'ESTIMATED'}}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['CLE', 'Lupus', 'Lupus Erythematosus'], 'conditions': ['Cutaneous Lupus Erythematosus (CLE)']}, 'descriptionModule': {'briefSummary': 'The Cutaneous Lupus Erythematosus (CLE) database, established in 2006, is a multi-site database between the University of Pennsylvania and the University of Texas Southwestern (UTSW).', 'detailedDescription': 'The database has yielded valuable information and clinical insights into the pathophysiology, disease processes, treatments and quality of life associated with CLE. The CLE database incorporates the CLASI (Cutaneous Lupus Activity and Severity Index), a validated outcome measure of disease responsiveness in patients and other assessment tools, surveys and patient information to help validate the clinical course and quality of life of patients with CLE (cutaneous lupus erythematosus).\n\nThe CLE database has led to publication of significant studies on lupus and its clinical course, the effect of lupus on Quality of Life (QoL), including the effect of photosensitivity on QoL, and the effect of first line medications.\n\nThe CLE database is an ongoing resource that enables clinicians to evaluate the evolving clinical changes, treatment modalities and patient response to a challenging disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects will be recruited from among the patients seen at the Autoimmune Skin Disease Clinic at the Hospital of the University of Pennsylvania and other collaborating centers.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects who meet the criteria for having CLE, using the Gilliam classifications, and/or a diagnosis of systemic lupus erythematosus (SLE), using the American Rheumatism Association/American College of Rheumatology criteria. Subjects must be 18 years or older.\n\nExclusion Criteria:\n\n* All subjects who do not meet the criteria for having CLE. Subjects who meet the criteria for CLE but who are not yet 18 years old'}, 'identificationModule': {'nctId': 'NCT01510067', 'briefTitle': 'Prevalence and Clinical Severity of Cutaneous Lupus Erythematosus', 'organization': {'class': 'OTHER', 'fullName': 'University of Pennsylvania'}, 'officialTitle': 'Prevalence and Clinical Severity of Cutaneous Lupus Erythematosus', 'orgStudyIdInfo': {'id': '805758'}}, 'contactsLocationsModule': {'locations': [{'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Victoria P Werth, MD', 'role': 'CONTACT', 'email': 'werth@pennmedicine.upenn.edu', 'phone': '215-615-2940'}, {'name': 'Joyce Okawa, RN', 'role': 'CONTACT', 'email': 'joyce.okawa@pennmedicine.upenn.edu', 'phone': '215-615-2940'}], 'facility': 'Hospital of the University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '75390', 'city': 'Dallas', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Benjamin Chong', 'role': 'CONTACT'}], 'facility': 'University of Texas Southwestern', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'centralContacts': [{'name': 'Victoria P Werth, MD', 'role': 'CONTACT', 'email': 'werth@pennmedicine.upenn.edu', 'phone': '215-615-2940'}, {'name': 'Joyce Okawa, R.N', 'role': 'CONTACT', 'email': 'Joyce.Okawa@pennmedicine.upenn.edu', 'phone': '215-615-2940'}], 'overallOfficials': [{'name': 'Victoria Werth, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pennsylvania'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pennsylvania', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Victoria Werth', 'investigatorAffiliation': 'University of Pennsylvania'}}}}