Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2026-02-26 @ 12:45 AM
Study NCT ID:
NCT07003451
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-28
First Post:
2025-05-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Novel Biomarkers in Assessment of Interstitial Lung Disease Associated With Rheumatoid Arthritis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}, {'id': 'D017563', 'term': 'Lung Diseases, Interstitial'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'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'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-22', 'studyFirstSubmitDate': '2025-05-26', 'studyFirstSubmitQcDate': '2025-05-26', 'lastUpdatePostDateStruct': {'date': '2025-08-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-06-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'calprotectin level among rheumatoid arthritis patients with interstitial lung disease', 'timeFrame': 'day 1', 'description': 'calprotectin level among rheumatoid arthritis patients with interstitial lung disease'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Rheumatoid Arthritis', 'Interstitial Lung Disease']}, 'referencesModule': {'references': [{'pmid': '34211592', 'type': 'BACKGROUND', 'citation': 'Furukawa H, Oka S, Higuchi T, Shimada K, Hashimoto A, Matsui T, Tohma S. Biomarkers for interstitial lung disease and acute-onset diffuse interstitial lung disease in rheumatoid arthritis. Ther Adv Musculoskelet Dis. 2021 Jun 18;13:1759720X211022506. doi: 10.1177/1759720X211022506. eCollection 2021.'}, {'pmid': '33451989', 'type': 'BACKGROUND', 'citation': 'Machahua C, Guler SA, Horn MP, Planas-Cerezales L, Montes-Worboys A, Geiser TK, Molina-Molina M, Funke-Chambour M. Serum calprotectin as new biomarker for disease severity in idiopathic pulmonary fibrosis: a cross-sectional study in two independent cohorts. BMJ Open Respir Res. 2021 Jan;8(1):e000827. doi: 10.1136/bmjresp-2020-000827.'}]}, 'descriptionModule': {'briefSummary': '\\- Assess Krebs von den Lungen-6 (KL-6) and Calprotectin as novel biomarkers for diagnosis of ILD among Rheumatoid arthritis patients', 'detailedDescription': 'Rheumatoid arthritis (RA) is a systemic autoimmune disease characterized by small joint synovitis that is estimated to affect 0.3% to 1% of the global population. Extraarticular disease may occur in up to 50% of patients with RA, with pulmonary manifestations among the most common extraarticular features. Interstitial lung disease (ILD) clinically affects up to 10% of patients with RA and subclinically affects up to 40%.\n\nRA-ILD typically presents as a usual interstitial pneumonia (UIP) or nonspecific interstitial pneumonia pattern. Diagnosis requires a thorough evaluation, including laboratory and imaging studies; pulmonary function testing (PFT); medication review; occasionally, tissue histopathology; and frequently, multidisciplinary input.\n\nPrompt recognition of RA-ILD is crucial because it warrants close monitoring and often necessitates therapeutic alterations.\n\nBiomarkers are a promising area of investigation in RA-ILD because they have the potential to advance pathophysiologic understanding and elucidate therapeutic targets, improve disease identification and diagnostic accuracy, facilitate prognostication, and inform treatment decisions. Although imaging and histopathology have important roles that are unlikely to be replaced by biomarkers, they can be nonspecific in RA-ILD, can be impractical to obtain in certain settings, and cannot be scaled for population health efforts.\n\nCalprotectin belongs to the S-100 proteins produced by neutrophils, which likely contribute to idiopathic pulmonary fibrosis (IPF) pathogenesis. Calprotectin is a well-established biomarker in inflammatory bowel diseases.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Confirmed diagnosis of Rheumatoid arthritis, age \\> 18 years and confirmed diagnosis of ILD based on HRCT findings and Pulmonary function test results.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Confirmed diagnosis of Rheumatoid arthritis, age \\> 18 years.\n\nExclusion Criteria:\n\n* Patients who refuse to participate in the study,\n* Patients with evidence of worsening or exacerbation of RA over the previous 6 months,\n* concomitant diagnosis of an active neoplasia, or\n* patients who had previously received radiotherapy,\n* End organ failure.'}, 'identificationModule': {'nctId': 'NCT07003451', 'briefTitle': 'Novel Biomarkers in Assessment of Interstitial Lung Disease Associated With Rheumatoid Arthritis Patients', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Novel Biomarkers in Assessment of Interstitial Lung Disease Associated With Rheumatoid Arthritis Patients', 'orgStudyIdInfo': {'id': 'RA-ILD-Associated-Biomarkers'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Rheumatoid Arthritis with ILD', 'description': 'Rheumatoid arthritis patients with interstitial lung disease diagnosed by high resolution CT and correlated to level of biomarkers', 'interventionNames': ['Diagnostic Test: Calprotectin Level']}], 'interventions': [{'name': 'Calprotectin Level', 'type': 'DIAGNOSTIC_TEST', 'description': "Measurement of calprotectin level to presence and severity of ILD asessed via Warrick's score", 'armGroupLabels': ['Rheumatoid Arthritis with ILD']}]}, 'contactsLocationsModule': {'locations': [{'zip': '71515', 'city': 'Asyut', 'country': 'Egypt', 'contacts': [{'name': 'Waleed Gamal Elddin, Ass. Prof', 'role': 'CONTACT', 'email': 'waleedgamalddin@yahoo.com', 'phone': '+21006519722'}, {'name': 'Ahmad M. Shaddad, Ass. Prof.', 'role': 'CONTACT', 'email': 'shaddad_ahmad@aun.edu.eg', 'phone': '+21111171930'}], 'facility': 'Assiut University hospital', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'centralContacts': [{'name': 'waleed gamal elddin, ass. prof', 'role': 'CONTACT', 'email': 'waleedgamalddin@yahoo.com', 'phone': '+201006519722'}, {'name': 'ahmad shaddad, ass. prof', 'role': 'CONTACT', 'email': 'Shaddad_ahmad@aun.edu.eg', 'phone': '+201111171930'}], 'overallOfficials': [{'name': 'waleed gamal elddin, ass. prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assiut University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor of chest diseases', 'investigatorFullName': 'Waleed Gamal Elddin Khaleel', 'investigatorAffiliation': 'Assiut University'}}}}