Ignite Creation Date:
2025-12-24 @ 9:24 PM
Ignite Modification Date:
2025-12-28 @ 12:36 PM
Study NCT ID:
NCT05900232
Status:
UNKNOWN
Last Update Posted:
2023-06-12
First Post:
2023-05-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Anti KU Antibodies and Its Relationship With Systemic Lupus Erythematosus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-01-24', 'releaseDate': '2024-12-08'}], 'estimatedResultsFirstSubmitDate': '2024-12-08'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D008180', 'term': 'Lupus Erythematosus, Systemic'}], 'ancestors': [{'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-05-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2023-11-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-06-08', 'studyFirstSubmitDate': '2023-05-27', 'studyFirstSubmitQcDate': '2023-06-08', 'lastUpdatePostDateStruct': {'date': '2023-06-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Anti KU antibodies and its relationship with Systemic Lupus Erythematosus manifestations', 'timeFrame': '6 months', 'description': 'the study will evaluate the titre of Anti KU\n\nantibodies which is positive or negative in one patient and on the other side what is the manifestation of SLE that found in the same patient if the Anti KU Antibodies titre is positive'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Systemic Lupus Erythematosus']}, 'referencesModule': {'references': [{'pmid': '17083771', 'type': 'BACKGROUND', 'citation': 'Mosca M, Bombardieri S. Assessing remission in systemic lupus erythematosus. Clin Exp Rheumatol. 2006 Nov-Dec;24(6 Suppl 43):S-99-104.'}, {'pmid': '22553077', 'type': 'BACKGROUND', 'citation': 'Petri M, Orbai AM, Alarcon GS, Gordon C, Merrill JT, Fortin PR, Bruce IN, Isenberg D, Wallace DJ, Nived O, Sturfelt G, Ramsey-Goldman R, Bae SC, Hanly JG, Sanchez-Guerrero J, Clarke A, Aranow C, Manzi S, Urowitz M, Gladman D, Kalunian K, Costner M, Werth VP, Zoma A, Bernatsky S, Ruiz-Irastorza G, Khamashta MA, Jacobsen S, Buyon JP, Maddison P, Dooley MA, van Vollenhoven RF, Ginzler E, Stoll T, Peschken C, Jorizzo JL, Callen JP, Lim SS, Fessler BJ, Inanc M, Kamen DL, Rahman A, Steinsson K, Franks AG Jr, Sigler L, Hameed S, Fang H, Pham N, Brey R, Weisman MH, McGwin G Jr, Magder LS. Derivation and validation of the Systemic Lupus International Collaborating Clinics classification criteria for systemic lupus erythematosus. Arthritis Rheum. 2012 Aug;64(8):2677-86. doi: 10.1002/art.34473.'}, {'pmid': '22129255', 'type': 'BACKGROUND', 'citation': 'Tsokos GC. Systemic lupus erythematosus. N Engl J Med. 2011 Dec 1;365(22):2110-21. doi: 10.1056/NEJMra1100359. No abstract available.'}, {'pmid': '12521194', 'type': 'BACKGROUND', 'citation': 'Mimori T. Clinical significance of anti-Ku autoantibodies--a serologic marker of overlap syndrome? Intern Med. 2002 Dec;41(12):1096-8. doi: 10.2169/internalmedicine.41.1096. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'systemic lupus Erythematosus (SLE) is a multi system autoimmune disorder abroad spectrum of clinical presentations.\n\nDiagnosis of SLE depending on Systemic Lupus International Collaborating Clinics (SLICC) Criteria.\n\nSLICC Criteria requires either that a patient satisfy at least 4 of 17 Criteria including at least 1 of 11 clinical criteria and 1 of 6 immunological criteria or the patient has biopsy -proven nephritis compatible with SLE in the presence of antinuclear antibodies (ANA)or anti\\_double stranded DNA (dsDNA) antibodies.\n\nAnti\\_KU antibodies included in (ANA), reported in many autoimmune disorders like SLE,Sjogren syndrome, idiopathic lung fibrosis and myositis.\n\nSo the aim of the work is to determine the relationship between Anti\\_KU antibodies and SLE manifestations.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '60 Years', 'minimumAge': '17 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* all patients will fulfill the Systemic Lupus International Clinics(SLICC) classification criteria for Systemic Lupus Erythematosus.\n\nExclusion Criteria:\n\n* any patient with any collagen disease other than SLE'}, 'identificationModule': {'nctId': 'NCT05900232', 'briefTitle': 'Anti KU Antibodies and Its Relationship With Systemic Lupus Erythematosus', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'Anti KU Antibodies and Its Relationship With Systemic Lupus Erythematosus', 'orgStudyIdInfo': {'id': 'Soh-Med-23-05-05MD'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Anti _KU antibodies', 'type': 'DIAGNOSTIC_TEST', 'description': 'aim of the work is to determine the relationship between Anti\\_Ku antibodies and SLE manifestations the study will include 60 SLE cases diagnosed by SLICC criteria and the activity of SLE will be calculated by SELDAI criteria, which is tool composed of 24 clinical and laboratory variables.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sohag', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Magdy M Amin, Professor', 'role': 'CONTACT'}], 'facility': 'Sohag University Hospitals', 'geoPoint': {'lat': 26.55695, 'lon': 31.69478}}], 'centralContacts': [{'name': 'Nehal A Ahmed, resident', 'role': 'CONTACT', 'email': 'nehal011209@med.sohag.edu.eg', 'phone': '01145379717'}, {'name': 'Osama S Daifallah, Associate Professor', 'role': 'CONTACT'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident Doctor at Rheumatology Department', 'investigatorFullName': 'Nehal Abdelbasset Ahmed', 'investigatorAffiliation': 'Sohag University'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2024-12-08', 'type': 'RELEASE'}, {'date': '2025-01-24', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Nehal Abdelbasset Ahmed, Resident Doctor at Rheumatology Department, Sohag University'}}}}