Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2026-02-25 @ 6:52 PM
Study NCT ID:
NCT05316805
Status:
RECRUITING
Last Update Posted:
2024-08-15
First Post:
2022-03-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
China Type II Inflammatory Skin Disease Clinical Research and Standardized Diagnosis and Treatment Project
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-08-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2031-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-13', 'studyFirstSubmitDate': '2022-03-18', 'studyFirstSubmitQcDate': '2022-03-29', 'lastUpdatePostDateStruct': {'date': '2024-08-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2031-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Demographics', 'timeFrame': 'baseline', 'description': 'Age, sex, ethnicity, body weight and height'}, {'measure': 'Age at Type 2 skin disease onset', 'timeFrame': 'baseline', 'description': 'Age of study patients at time of Type 2 skin disease onset'}, {'measure': 'Type of current Type 2 skin disease therapy', 'timeFrame': 'Baseline', 'description': 'Type of therapy administered to treat Type 2 skin disease (e.g., systemic, topical, other)'}, {'measure': 'Presence of Type 2 skin disease and selected comorbid conditions', 'timeFrame': 'Baseline to Month 120', 'description': 'Percentage of patients with Type 2 skin disease and selected comorbidities (e.g., asthma and allergic rhinitis) at baseline and during study'}], 'secondaryOutcomes': [{'measure': 'Percentage of patients using specific Type 2 skin disease therapies and initiating new therapies', 'timeFrame': 'Baseline to Month 120', 'description': 'Percentage of patients using specific Type 2 skin disease therapies and initiating new therapies'}, {'measure': 'Eczema Area and Severity Index (EASI)', 'timeFrame': 'Baseline to Month 120', 'description': 'EASI score as assessed by physician'}, {'measure': 'Body Surface Area (BSA) percentage affected by Type 2 skin disease', 'timeFrame': 'Baseline to Month 120', 'description': 'BSA score as assessed by physician'}, {'measure': 'Patient Oriented Eczema Measure (POEM) questionnaire', 'timeFrame': 'Baseline to Month 120', 'description': "POEM score as reported by the participant's caregiver"}, {'measure': 'Dermatology Life Quality Index', 'timeFrame': 'Baseline to Month 120', 'description': 'DLQI score as reported by the patients or caregivers'}, {'measure': 'Bullous Pemphigoid Disease Area Index(BPDAI)', 'timeFrame': 'Baseline to Month 120', 'description': 'BPDAI score as assessed by physician'}, {'measure': 'Autoimmune Bullous Skin Disorder Intensity Score (ABSIS)', 'timeFrame': 'Baseline to Month 120', 'description': 'ABSIS score as assessed by physician'}, {'measure': 'Chronic Urticaria Quality of Life questionnaire (CU-Q2oL)', 'timeFrame': 'Baseline to Month 120', 'description': 'CU-Q2oL score as assessed by patients or caregivers'}, {'measure': 'Urticaria Activity Score 7a （UAS7a）', 'timeFrame': 'Baseline to Month 120', 'description': 'UAS7a score as assessed by physician'}, {'measure': 'Urticaria Control test (UCT)', 'timeFrame': 'Baseline to Month 120', 'description': 'UCT score as assessed by patients or caregivers'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Atopic Dermatitis Eczema', 'Prurigo Nodularis']}, 'referencesModule': {'references': [{'pmid': '38431766', 'type': 'DERIVED', 'citation': 'Zhao J, Zhang Z, Chen H, Dou X, Zhao Z, Liu L, Wang Y, Li H. Associations of demographics, aggravating factors, comorbidities, and treatments with atopic dermatitis severity in China: A national cross-sectional study. Chin Med J (Engl). 2024 Mar 3;138(5):553-561. doi: 10.1097/CM9.0000000000003042. Epub 2024 Mar 3.'}]}, 'descriptionModule': {'briefSummary': 'In order to further improve the diagnosis and treatment level of type 2 inflammatory skin diseases, the National Clinical Center for Skin and Immune Diseases established a standardized diagnosis and treatment center for type 2 inflammatory skin diseases to systematically and effectively understand the current treatment status of patients with type 2 inflammatory skin diseases, as well as the efficacy and safety of various treatment methods during practices, so as to further improve the diagnosis and treatment level of type 2 inflammatory skin diseases and help patients with type 2 inflammatory skin diseases.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with Type 2 skin disease. Estimated number of patients: 100,000 (No age limit)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients from the medical units that has passed the data review of the National Clinical Center for Skin and Immune Diseases (see the study sites for data collection for details);\n2. patients diagnosed with type 2 inflammatory skin diseases (dermatitis/eczema, urticaria, pemphigoid, prurigo nodularis).\n\nExclusion Criteria:\n\n1. patients who fail to provide informed consent form;\n2. patients who cannot complete the questionnaire independently or under the guidance of investigators'}, 'identificationModule': {'nctId': 'NCT05316805', 'acronym': 'CORNERSTONE', 'briefTitle': 'China Type II Inflammatory Skin Disease Clinical Research and Standardized Diagnosis and Treatment Project', 'organization': {'class': 'OTHER', 'fullName': 'Peking University First Hospital'}, 'officialTitle': 'China Type II Inflammatory Skin Disease Clinical Research and Standardized Diagnosis and Treatment Project: a National Multicenter Prospective Cohort Study', 'orgStudyIdInfo': {'id': 'PKU202108'}}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yang Wang, Doctor', 'role': 'CONTACT', 'email': 'yangwang_dr@bjmu.edu.cn', 'phone': '008613811232795'}], 'facility': 'Peking University First Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Yang Wang, Doctor', 'role': 'CONTACT', 'email': 'yangwang_dr@bjmu.edu.cn', 'phone': '008613811232795'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking University First Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}