Ignite Creation Date:
2025-12-24 @ 11:58 AM
Ignite Modification Date:
2025-12-31 @ 3:50 AM
Study NCT ID:
NCT00004761
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
2000-02-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Establishment of the National Epidermolysis Bullosa Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004820', 'term': 'Epidermolysis Bullosa'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D035583', 'term': 'Rare Diseases'}], 'ancestors': [{'id': 'D012868', 'term': 'Skin Abnormalities'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D012873', 'term': 'Skin Diseases, Genetic'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012872', 'term': 'Skin Diseases, Vesiculobullous'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'NATURAL_HISTORY'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1986-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2004-07', 'lastUpdateSubmitDate': '2005-06-23', 'studyFirstSubmitDate': '2000-02-24', 'studyFirstSubmitQcDate': '2000-02-24', 'lastUpdatePostDateStruct': {'date': '2005-06-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2000-02-25', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['dermatologic disorders', 'epidermolysis bullosa', 'genetic diseases and dysmorphic syndromes', 'rare disease'], 'conditions': ['Epidermolysis Bullosa']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Lin AN, Carter DM: Epidermolysis Bullosa: Basic and Clinical Aspects. New York: Springer Verlag, 1992.'}]}, 'descriptionModule': {'briefSummary': 'OBJECTIVES: I. Develop a large roster of well-characterized patients with various forms of inherited and acquired epidermolysis bullosa (EB).\n\nII. Generate a large data bank of clinical, historical, and genetic information concerning these patients.\n\nIII. Accumulate donated tissue specimens, including selected cells and DNA, from selected patient subsets for the establishment of permanent tissue cell banks.\n\nIV. Promote and facilitate research in EB.', 'detailedDescription': 'PROTOCOL OUTLINE: Patients are enrolled by mail or clinic visit at 1 of 4 clinical centers. Clinical, epidemiological, and laboratory data are collected.\n\nMedical and family histories are obtained in a detailed interview in person, by phone, or by mail. Diagnostic studies to confirm the type of epidermolysis bullosa are performed as indicated. A pedigree chart is completed on the first affected family member entered.\n\nSelected patients are followed at least biannually. A study duration of approximately 10 years is anticipated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '0 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '* Clinical diagnosis of epidermolysis bullosa'}, 'identificationModule': {'nctId': 'NCT00004761', 'briefTitle': 'Establishment of the National Epidermolysis Bullosa Registry', 'organization': {'class': 'NIH', 'fullName': 'Office of Rare Diseases (ORD)'}, 'orgStudyIdInfo': {'id': '199/11706'}, 'secondaryIdInfos': [{'id': 'RU-0170195'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'James G. Krueger', 'role': 'STUDY_CHAIR', 'affiliation': 'Rockefeller University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Center for Research Resources (NCRR)', 'class': 'NIH'}, 'collaborators': [{'name': 'National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)', 'class': 'NIH'}, {'name': 'Rockefeller University', 'class': 'OTHER'}]}}}