Ignite Creation Date:
2025-12-25 @ 2:56 AM
Ignite Modification Date:
2025-12-31 @ 2:56 AM
Study NCT ID:
NCT04234633
Status:
UNKNOWN
Last Update Posted:
2020-01-21
First Post:
2020-01-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Gender on Clinical Presentation of SLE ِAt Assiut University Hospitals
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2022-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-01-16', 'studyFirstSubmitDate': '2020-01-11', 'studyFirstSubmitQcDate': '2020-01-16', 'lastUpdatePostDateStruct': {'date': '2020-01-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Presentation, complication, and mortality among males and female patients with SLE', 'timeFrame': '2 years', 'description': 'Using percentages, we will track the number of patients that develop certain clinical conditions (such as arthritis, malar rash, .... ), complications (such as nephritis), and mortality rates. These numbers and percentages will be used to compare males with females (incidence rates for each event will be calculated).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['SLE']}, 'referencesModule': {'references': [{'pmid': '10342711', 'type': 'RESULT', 'citation': 'Mok CC, Lau CS, Chan TM, Wong RW. Clinical characteristics and outcome of southern Chinese males with systemic lupus erythematosus. Lupus. 1999;8(3):188-96. doi: 10.1191/096120399678847605.'}, {'pmid': '15638045', 'type': 'RESULT', 'citation': 'Soto ME, Vallejo M, Guillen F, Simon JA, Arena E, Reyes PA. Gender impact in systemic lupus erythematosus. Clin Exp Rheumatol. 2004 Nov-Dec;22(6):713-21.'}, {'pmid': '29431056', 'type': 'RESULT', 'citation': 'El Hadidi KT, Medhat BM, Abdel Baki NM, Abdel Kafy H, Abdelrahaman W, Yousri AY, Attia DH, Eissa M, El Dessouki D, Elgazzar I, Elgengehy FT, El Ghobashy N, El Hadary H, El Mardenly G, El Naggar H, El Nahas AM, El Refai RM, El Rwiny HA, Elsman RM, Galal M, Ghoniem S, Maged LA, Sally SM, Naji H, Saad S, Shaaban M, Sharaf M, Sobhy N, Soliman RM, El Hadidi TS. Characteristics of systemic lupus erythematosus in a sample of the Egyptian population: a retrospective cohort of 1109 patients from a single center. Lupus. 2018 May;27(6):1030-1038. doi: 10.1177/0961203317751856. Epub 2018 Feb 10.'}]}, 'descriptionModule': {'briefSummary': 'The investigators aim to compare the clinical characteristics and outcomes of SLE between male and female Egyptian patients at Assuit University Hospital.', 'detailedDescription': "Systemic lupus erythematosus (SLE) is an autoimmune disease of unknown etiology and is characterized by a multifaceted clinical presentation and disease course. Female predominance is a well-known characteristic of SLE, particularly during the reproductive years. Sex differences are another peculiarity of SLE with respect to clinical manifestations and outcomes. Previous studies have recognized male patients with lupus as a distinct minority; such patients often exhibit a poorer prognosis, especially involving the renal, cardiovascular, and neurologic systems. Higher mortality rates in male than in female patients with SLE have also been reported. Andrade et al reported that multiple conditions (for example, severe skin lesions, serositis, thrombotic events, and seizures) are more frequent in males than females.\n\nLu et al investigated the frequency of renal failure and end-stage renal disease among both genders and found out that these conditions were more prevalent among males. Another study shows no difference in complications and prognosis between both genders.\n\nThe results of these previous studies may not be applicable to all ethnic groups. For example, Mok et al studied the males in the local Chinese population had different disease features in term of clinical features at diagnosis, rate, and severity of relapse, organ damage and cumulative damage score. They found through a retrospective review that at the time of diagnosis, there was a trend, however not statistically significant, that males had less Raynaud's, alopecia, arthritis, anti-Ro antibody, but more thrombocytopenia and discoid lesions. Also, a significantly higher number of males had impaired renal functions.\n\nThere are few studies that have assessed the differences between male and female Egyptian patients with SLE according to the presentation, complication, prognosis, and mortality. One of these studies shows a more aggressive disease detected in male patients. This was evident by a higher prevalence of nephritis, fever, cutaneous vasculitis in male patients. on the other hand, alopecia and arthritis were significantly higher in females."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Any SLE patients between 18and 40 years old will be eligible to be included in our study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n• Any SLE patients between 18and 40 years old will be eligible to be included in our study.\n\nExclusion Criteria:\n\n* Patients below the age of 18 or above 40.\n* Any other autoimmune disease.\n* Cardiovascular, neurological, renal complications due to other co-morbidity such as DM and HTN.'}, 'identificationModule': {'nctId': 'NCT04234633', 'briefTitle': 'Effect of Gender on Clinical Presentation of SLE ِAt Assiut University Hospitals', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Effect of Gender on Clinical Presentation of SLE ِAt Assiut University Hospitals', 'orgStudyIdInfo': {'id': 'A44'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'SLE patients', 'description': 'Any SLE patients between 18 and 40 years old.'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Ahmed Aeltaih, MBBch', 'role': 'CONTACT', 'email': 'a.safwat.4842@gmail.com', 'phone': '+201159486891'}], 'overallOfficials': [{'name': 'Ahmed Aeltaih, MBBch', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assuit University Hospitals'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'No data will be shared.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Ahmed Safwat ِِِAbd elhamid eltaih', 'investigatorAffiliation': 'Assiut University'}}}}