Ignite Creation Date:
2025-12-24 @ 11:47 PM
Ignite Modification Date:
2026-01-02 @ 3:55 PM
Study NCT ID:
NCT06579651
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-08-30
First Post:
2024-08-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nailfold Capillaroscopic Pattern Changes and Its Correlation with Interstitial Lung Disease (ILD) in Systemic Sclerosis (SSc) Patients.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012595', 'term': 'Scleroderma, Systemic'}], 'ancestors': [{'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020678', 'term': 'Microscopic Angioscopy'}], 'ancestors': [{'id': 'D000069416', 'term': 'Intravital Microscopy'}, {'id': 'D008853', 'term': 'Microscopy'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D003935', 'term': 'Diagnostic Techniques, Cardiovascular'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 45}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2025-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-29', 'studyFirstSubmitDate': '2024-08-29', 'studyFirstSubmitQcDate': '2024-08-29', 'lastUpdatePostDateStruct': {'date': '2024-08-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Nail fold capillary pattern changes in SSc patients', 'timeFrame': 'baseline'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Systemic Sclerosis (SSc)']}, 'descriptionModule': {'briefSummary': 'Detection of different pattern of nail fold capillary changes in SSc patients. Correlation of nail fold capillary changes in SSc patients with ILD.', 'detailedDescription': 'SSc is a connective tissue disease characterized by early microvascular damage and dysfunction and immune system activation, as well as progressive fibrosis in the skin and internal organs.\n\nNailfold videocapillaroscopy (NVC) is the validated technique to assess SSc microvascular damage and is useful for the early diagnosis and follow-up of SSc micro- angiopathy.\n\nSeveral studies have demonstrated correlations between microvascular damage extent and the severity of internal organ involvement, showing that NVC abnormalities correlate with disease activity and severity and may be also predictive for disease worsening. Furthermore, successful treatments have been shown to reduce NVC abnormalities in SSc cases, and these findings support the importance of NVC in monitoring SSc patients and also suggest its possible role as an outcome measure for microangiopathy in clinical trials.\n\nThree different NVC patterns of microvascular damage have been described (\\"early\\" , \\"active\\" , \\"late\\" ).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'cross sectional', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult SSc Patients\n\nExclusion Criteria:\n\n\\- 1-SSc patients aged less than 18 years old. 2-Individuals with other autoimmune diseases (rheumatoid arthritis, dermatomyositis, connective tissue disease).\n\n3-Congestive heart failure and presence of clubbing. 4-history of smoking. 5-Patients unable to co-operate for nail fold capillaroscopic examination.'}, 'identificationModule': {'nctId': 'NCT06579651', 'briefTitle': 'Nailfold Capillaroscopic Pattern Changes and Its Correlation with Interstitial Lung Disease (ILD) in Systemic Sclerosis (SSc) Patients.', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Nailfold Capillaroscopic Pattern Changes and Its Correlation with Interstitial Lung Disease (ILD) in Systemic Sclerosis (SSc) Patients.', 'orgStudyIdInfo': {'id': 'NVC in SSc patients'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Nailfold videocapillaroscopy (NVC)', 'type': 'DEVICE', 'description': 'Nailfold videocapillaroscopy (NVC) is the validated technique to assess SSc microvascular damage and is useful for the early diagnosis and follow-up of SSc micro- angiopathy.'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Mennatullah Salaheldin', 'role': 'CONTACT', 'email': 'mennasalaheldin88@gmail.com', 'phone': '+201010616746'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Mennatullah Salaheldin Mohamed', 'investigatorFullName': 'Mennatullah Salaheldin', 'investigatorAffiliation': 'Assiut University'}}}}