Ignite Creation Date:
2025-12-25 @ 3:32 AM
Ignite Modification Date:
2026-02-26 @ 12:04 PM
Study NCT ID:
NCT05943405
Status:
COMPLETED
Last Update Posted:
2023-07-13
First Post:
2023-06-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Disease Severity In Patients With Psoriasis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011565', 'term': 'Psoriasis'}], 'ancestors': [{'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'NONE_RETAINED', 'description': '5 cc of blood was drawn for GGT, hs-CRP, and apo B examinations.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2022-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-04', 'studyFirstSubmitDate': '2023-06-25', 'studyFirstSubmitQcDate': '2023-07-04', 'lastUpdatePostDateStruct': {'date': '2023-07-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Gamma-Glutamyl Transferase', 'timeFrame': 'only in admission', 'description': 'Gamma-Glutamyl Transferase was check in admission, reference range for adults is 5 to 40 U/L (units per liter)'}, {'measure': 'Apolipoprotein B', 'timeFrame': 'only in admission', 'description': 'Apolipoprotein B (ApoB) is the primary apolipoprotein and is the carrier for the following lipids: chylomicrons, low-density lipoprotein ( LDL), very low-density lipoprotein (VLDL), intermediate-density lipoprotein (IDL), and lipoprotein. Unit used in mg/dL'}, {'measure': 'High-sensitivity c-reactive protein', 'timeFrame': 'only in admission', 'description': 'High-sensitivity C-reactive protein (hsCRP) is a marker of inflammation that predicts incident myocardial infarction, stroke, peripheral arterial disease, and sudden cardiac death. Unit used in mg/L'}, {'measure': 'PASI', 'timeFrame': 'only in admission', 'description': 'A PASI (The Psoriasis Area and Severity Index) score can range from 0 to 72'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Psoriasis', 'Psoriasis Area and Severity Index', 'Gamma-Glutamyl Transferase', 'CRP', 'Apolipoprotein B'], 'conditions': ['Psoriasis']}, 'referencesModule': {'references': [{'pmid': '34181079', 'type': 'BACKGROUND', 'citation': 'Sholihah MM, Kusuma TRH, Hanif MI, Prabowo NA. Letter to the Editor on Type 1 diabetes onset triggered by COVID-19. Acta Diabetol. 2021 Sep;58(9):1283-1284. doi: 10.1007/s00592-021-01761-3. Epub 2021 Jun 28. No abstract available.'}, {'pmid': '34912736', 'type': 'RESULT', 'citation': 'Pratama YS, Pradiptakirana R, Rachmah A, Prabowo NA. Autoimmune Thrombocytopenia in SLE and COVID-19. Eur J Case Rep Intern Med. 2021 Nov 3;8(11):002863. doi: 10.12890/2021_002863. eCollection 2021.'}]}, 'descriptionModule': {'briefSummary': 'This observational study aims to evaluate new markers to predict disease activity in psoriasis. The main question is SGOT, SGPT, GGT, hs-CRP, and apo B related to disease severity in psoriasis.', 'detailedDescription': 'Psoriasis patients who had signed an informed consent were assessed for PASI scores and 5 cc of blood was drawn for GGT, hs-CRP, and apo B examinations. A PASI score is a tool used to measure the severity and extent of psoriasis. PASI is an acronym for Psoriasis Area and Severity Index.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Psoriasis Patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of Psoriasis\n\nExclusion Criteria:\n\n* Heart Failure\n* Diabetes Mellitus\n* Kidney Disease'}, 'identificationModule': {'nctId': 'NCT05943405', 'briefTitle': 'The Disease Severity In Patients With Psoriasis', 'organization': {'class': 'OTHER', 'fullName': 'Universitas Sebelas Maret'}, 'officialTitle': 'The Disease Severity In Patients With Psoriasis', 'orgStudyIdInfo': {'id': 'NAP07'}}, 'contactsLocationsModule': {'locations': [{'zip': '57161', 'city': 'Sukoharjo', 'state': 'Central Java', 'country': 'Indonesia', 'facility': 'Universitas Sebelas Maret Hospital', 'geoPoint': {'lat': -7.73778, 'lon': 110.49861}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitas Sebelas Maret', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Hospital Research Unit', 'investigatorFullName': 'Nurhasan Agung Prabowo, MD', 'investigatorAffiliation': 'Universitas Sebelas Maret'}}}}