Nctid:
NCT06235645
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-03"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000001168", "term"=>"Arthritis"}, {"id"=>"D000001172", "term"=>"Arthritis, Rheumatoid"}, {"id"=>"D000008171", "term"=>"Lung Diseases"}, {"id"=>"D000017563", "term"=>"Lung Diseases, Interstitial"}], "ancestors"=>[{"id"=>"D000007592", "term"=>"Joint Diseases"}, {"id"=>"D000009140", "term"=>"Musculoskeletal Diseases"}, {"id"=>"D000012216", "term"=>"Rheumatic Diseases"}, {"id"=>"D000003240", "term"=>"Connective Tissue Diseases"}, {"id"=>"D000001327", "term"=>"Autoimmune Diseases"}, {"id"=>"D000007154", "term"=>"Immune System Diseases"}, {"id"=>"D000012140", "term"=>"Respiratory Tract Diseases"}], "browseLeaves"=>[{"id"=>"M11168", "name"=>"Lung Diseases", "asFound"=>"Lung Disease", "relevance"=>"HIGH"}, {"id"=>"M19813", "name"=>"Lung Diseases, Interstitial", "asFound"=>"Interstitial Lung Disease", "relevance"=>"HIGH"}, {"id"=>"M4476", "name"=>"Arthritis", "asFound"=>"Arthritis", "relevance"=>"HIGH"}, {"id"=>"M4480", "name"=>"Arthritis, Rheumatoid", "asFound"=>"Rheumatoid Arthritis", "relevance"=>"HIGH"}, {"id"=>"M10621", "name"=>"Joint Diseases", "relevance"=>"LOW"}, {"id"=>"M12097", "name"=>"Musculoskeletal Diseases", "relevance"=>"LOW"}, {"id"=>"M15045", "name"=>"Rheumatic Diseases", "relevance"=>"LOW"}, {"id"=>"M6323", "name"=>"Collagen Diseases", "relevance"=>"LOW"}, {"id"=>"M6464", "name"=>"Connective Tissue Diseases", "relevance"=>"LOW"}, {"id"=>"M4629", "name"=>"Autoimmune Diseases", "relevance"=>"LOW"}, {"id"=>"M10200", "name"=>"Immune System Diseases", "relevance"=>"LOW"}, {"id"=>"M14977", "name"=>"Respiratory Tract Diseases", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Respiratory Tract (Lung and Bronchial) Diseases", "abbrev"=>"BC08"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Musculoskeletal Diseases", "abbrev"=>"BC05"}, {"name"=>"Skin and Connective Tissue Diseases", "abbrev"=>"BC17"}, {"name"=>"Immune System Diseases", "abbrev"=>"BC20"}]}}, "protocolSection"=>{"designModule"=>{"studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"PROSPECTIVE", "observationalModel"=>"CASE_ONLY"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>280}, "patientRegistry"=>false}, "statusModule"=>{"overallStatus"=>"NOT_YET_RECRUITING", "startDateStruct"=>{"date"=>"2024-09", "type"=>"ESTIMATED"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-07", "completionDateStruct"=>{"date"=>"2027-03", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-07-19", "studyFirstSubmitDate"=>"2024-01-23", "studyFirstSubmitQcDate"=>"2024-01-23", "lastUpdatePostDateStruct"=>{"date"=>"2024-07-22", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-02-01", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2026-09", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Determination sensitivity and specificity of thoracic ultrasound", "timeFrame"=>"2 years", "description"=>"The primary outcome is to determine the sensitivity and specificity of thoracic ultrasound defined as pathological by a total number of B lines ≥ 9 and/or pleural line thickening ≥ 3mm and/or a percentage of pleural line irregularity ≥ 24%."}], "secondaryOutcomes"=>[{"measure"=>"Percentage of each of the 3 ultrasound signs among pathological ultrasounds.", "timeFrame"=>"2 years", "description"=>"The secondary outcome is the percentage of each of the 3 ultrasound signs among pathological ultrasounds."}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["Lung ultrasound", "Rheumatoid Arthritis", "Interstitial Lung Disease"], "conditions"=>["Rheumatoid Arthritis", "Interstitial Lung Disease", "Thoracic Ultrasound", "Lung Ultrasound"]}, "referencesModule"=>{"references"=>[{"pmid"=>"9279235", "type"=>"RESULT", "citation"=>"Gabbay E, Tarala R, Will R, Carroll G, Adler B, Cameron D, Lake FR. Interstitial lung disease in recent onset rheumatoid arthritis. Am J Respir Crit Care Med. 1997 Aug;156(2 Pt 1):528-35. doi: 10.1164/ajrccm.156.2.9609016."}, {"pmid"=>"20851924", "type"=>"RESULT", "citation"=>"Olson AL, Swigris JJ, Sprunger DB, Fischer A, Fernandez-Perez ER, Solomon J, Murphy J, Cohen M, Raghu G, Brown KK. Rheumatoid arthritis-interstitial lung disease-associated mortality. Am J Respir Crit Care Med. 2011 Feb 1;183(3):372-8. doi: 10.1164/rccm.201004-0622OC. Epub 2010 Sep 17."}, {"pmid"=>"28611082", "type"=>"RESULT", "citation"=>"Hyldgaard C, Hilberg O, Pedersen AB, Ulrichsen SP, Lokke A, Bendstrup E, Ellingsen T. A population-based cohort study of rheumatoid arthritis-associated interstitial lung disease: comorbidity and mortality. Ann Rheum Dis. 2017 Oct;76(10):1700-1706. doi: 10.1136/annrheumdis-2017-211138. Epub 2017 Jun 13."}, {"pmid"=>"17684286", "type"=>"RESULT", "citation"=>"Brown KK. Rheumatoid lung disease. Proc Am Thorac Soc. 2007 Aug 15;4(5):443-8. doi: 10.1513/pats.200703-045MS."}, {"pmid"=>"20155830", "type"=>"RESULT", "citation"=>"Bongartz T, Nannini C, Medina-Velasquez YF, Achenbach SJ, Crowson CS, Ryu JH, Vassallo R, Gabriel SE, Matteson EL. Incidence and mortality of interstitial lung disease in rheumatoid arthritis: a population-based study. Arthritis Rheum. 2010 Jun;62(6):1583-91. doi: 10.1002/art.27405."}, {"pmid"=>"23983768", "type"=>"RESULT", "citation"=>"Chen J, Shi Y, Wang X, Huang H, Ascherman D. Asymptomatic preclinical rheumatoid arthritis-associated interstitial lung disease. Clin Dev Immunol. 2013;2013:406927. doi: 10.1155/2013/406927. Epub 2013 Jul 31."}, {"pmid"=>"11462065", "type"=>"RESULT", "citation"=>"Dawson JK, Fewins HE, Desmond J, Lynch MP, Graham DR. Fibrosing alveolitis in patients with rheumatoid arthritis as assessed by high resolution computed tomography, chest radiography, and pulmonary function tests. Thorax. 2001 Aug;56(8):622-7. doi: 10.1136/thorax.56.8.622."}, {"pmid"=>"33303554", "type"=>"RESULT", "citation"=>"Matson S, Lee J, Eickelberg O. Two sides of the same coin? A review of the similarities and differences between idiopathic pulmonary fibrosis and rheumatoid arthritis-associated interstitial lung disease. Eur Respir J. 2021 May 13;57(5):2002533. doi: 10.1183/13993003.02533-2020. Print 2021 May."}, {"pmid"=>"32428513", "type"=>"RESULT", "citation"=>"Kawano-Dourado L, Doyle TJ, Bonfiglioli K, Sawamura MVY, Nakagawa RH, Arimura FE, Lee HJ, Rangel DAS, Bueno C, Carvalho CRR, Sabbag ML, Molina C, Rosas IO, Kairalla RA. Baseline Characteristics and Progression of a Spectrum of Interstitial Lung Abnormalities and Disease in Rheumatoid Arthritis. Chest. 2020 Oct;158(4):1546-1554. doi: 10.1016/j.chest.2020.04.061. Epub 2020 May 16."}, {"pmid"=>"27788297", "type"=>"RESULT", "citation"=>"Zamora-Legoff JA, Krause ML, Crowson CS, Ryu JH, Matteson EL. Progressive Decline of Lung Function in Rheumatoid Arthritis-Associated Interstitial Lung Disease. Arthritis Rheumatol. 2017 Mar;69(3):542-549. doi: 10.1002/art.39971."}, {"pmid"=>"24567921", "type"=>"RESULT", "citation"=>"Mohammadi A, Oshnoei S, Ghasemi-rad M. Comparison of a new, modified lung ultrasonography technique with high-resolution CT in the diagnosis of the alveolo-interstitial syndrome of systemic scleroderma. Med Ultrason. 2014 Mar;16(1):27-31. doi: 10.11152/mu.2014.2066.161.am1so2."}, {"pmid"=>"31675455", "type"=>"RESULT", "citation"=>"Manolescu D, Oancea C, Timar B, Traila D, Malita D, Birsasteanu F, Tudorache V. Ultrasound mapping of lung changes in idiopathic pulmonary fibrosis. Clin Respir J. 2020 Jan;14(1):54-63. doi: 10.1111/crj.13101. Epub 2019 Nov 14."}, {"pmid"=>"26315813", "type"=>"RESULT", "citation"=>"Pinal-Fernandez I, Pallisa-Nunez E, Selva-O'Callaghan A, Castella-Fierro E, Simeon-Aznar CP, Fonollosa-Pla V, Vilardell-Tarres M. Pleural irregularity, a new ultrasound sign for the study of interstitial lung disease in systemic sclerosis and antisynthetase syndrome. Clin Exp Rheumatol. 2015 Jul-Aug;33(4 Suppl 91):S136-41. Epub 2015 Aug 27."}, {"pmid"=>"31267321", "type"=>"RESULT", "citation"=>"Gutierrez M, Tardella M, Rodriguez L, Mendoza J, Clavijo-Cornejo D, Garcia A, Bertolazzi C. Ultrasound as a potential tool for the assessment of interstitial lung disease in rheumatic patients. Where are we now? Radiol Med. 2019 Oct;124(10):989-999. doi: 10.1007/s11547-019-01053-5. Epub 2019 Jul 2."}, {"pmid"=>"24692573", "type"=>"RESULT", "citation"=>"Cogliati C, Antivalle M, Torzillo D, Birocchi S, Norsa A, Bianco R, Costantino G, Ditto MC, Battellino M, Sarzi Puttini PC, Montano N. Standard and pocket-size lung ultrasound devices can detect interstitial lung disease in rheumatoid arthritis patients. Rheumatology (Oxford). 2014 Aug;53(8):1497-503. doi: 10.1093/rheumatology/keu033. Epub 2014 Mar 31."}]}, "descriptionModule"=>{"briefSummary"=>"Rheumatoid arthritis is an autoimmune disease that can affect various organs, including the lungs, and lead to rheumatoid arthritis-interstitial lung disease (RA-ILD).\n\nRA-ILD is responsible for increased mortality in rheumatoid arthristis (RA) patients.\n\nThe prevalence of RA-ILD varies according to the screening tool used.\n\nThe current gold standard is chest CT, but this is an expensive, time-consuming and irradiating examination, and recommendations on when and how often it should be performed are not clearly established.\n\nLung ultrasound (LUS) is an emerging tool for the detection of lung parenchymal damage, particularly in systemic scleroderma and idiopathic pulmonary fibrosis (IPF).\n\nLUS is a non-irradiating, non-expensive examination that can be performed rapidly.\n\nThe aim of our study is to evaluate LUS as a screening tool for RA-ILD, in patients with risk factors for developing RA-ILD.", "detailedDescription"=>"Patients with RA and who have risk factors for RA-ILD are regularly reassessed in a rheumatology day hospital.\n\nAs part of their routine follow-up, and given the absence of recommendations on screening for RA-ILD in this population, chest CT and PFT (pulmonary function tests) are regularly performed at the request of the rheumatologist.\n\nTherefore, all patients meeting the inclusion criteria and having undergone chest CT and PFT in the 6 months preceding or following their rheumatology reassessment will be offered participation in the study.\n\nParticipation in the study does not alter the patient's usual follow-up.\n\nObjective of the study: evaluate the sensitivity and specificity of thoracic ultrasound compare to the chest CT in patients with risk factors of developing RA-ILD.\n\nDesign: This is a non-interventional, prospective, single-center, multidisciplinary study."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "samplingMethod"=>"NON_PROBABILITY_SAMPLE", "studyPopulation"=>"Adult patients followed at CHU de Tours with a diagnosis of rheumatoid arthritis and with at least two risk factors for developing PR-PID", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Adult patient (age \\> 18 years) followed at CHU of Tours\n* Diagnosis of rheumatoid arthritis validated according to ACR 2010 criteria, EULAR classification, regardless of time since diagnosis\n* Patient who has had or will have a thoracic CT scan and PFT performed as part of routine care in the 6 months preceding or following inclusion\n* Patient with at least two risk factors for developing RA-ILD among :\n\n * Male sex or\n * Active or former smoker assessed at 20 pack-year or\n * Age \\> 60 years or\n * Levels of RF≥3N (rheumatoid factor) and/or anti-CCP≥3N (antibodies against cyclic citrullinated peptides) at diagnosis or at any time during the course of the disease or\n * High RA activity score (DAS28\\>3.2)\n\nExclusion Criteria:\n\n* Diagnosis of congenital lung disease\n* Diagnosis of another autoimmune pathology associated with RA (overlap syndrome) linked to the development of ILD (interstitial lung disease) (systemic sclerosis, myositis, dermatomyositis, mixed connectivitis, systemic lupus erythematosus or other ANCA vasculitis, with the exception of secondary Gougerot-Sjögren's syndromes).\n* Current or operated lung cancer\n* Thoracic irradiation\n* Thoracic transplant patients\n* Previous invasive thoracic procedures\n* Pathologies responsible for pleural thickening (silicosis, asbestosis, known pleural plaque, pleural sequelae of tuberculosis)\n* Pregnant or breast-feeding women\n* Patient under legal protection (guardianship, curatorship or safeguard of justice)\n* Patient who has objected to data processing\n* Parenchymal infection current or less than one month old prior to LUS examination\n* Liquid or gaseous pleural effusion"}, "identificationModule"=>{"nctId"=>"NCT06235645", "acronym"=>"EARLIER", "briefTitle"=>"dEtection of rheumAtoid aRthritis - Interstitial Lung dIseasE by Thoracic ultRasound", "organization"=>{"class"=>"OTHER", "fullName"=>"University Hospital, Tours"}, "officialTitle"=>"dEtection of rheumAtoid aRthritis - Interstitial Lung dIseasE by Thoracic ultRasound", "orgStudyIdInfo"=>{"id"=>"DR230226 - EARLIER"}}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"Lung ultrasound (LUS)", "type"=>"DIAGNOSTIC_TEST", "description"=>"If included, an LUS will be performed by an experienced operator, blinded to the results of the chest CT and PFT.\n\nA linear probe (4 to 12 MHz) will be used. The patient will be installed́ in a semi-seated position with the homolateral arm above the head for the anterior and axillary evaluation then, depending on his comfort, in a seated position or in right then left lateral decubitus, arms alongside the body, for the posterior evaluation. It will be practiced by experienced operators (pneumologist) and according to a validated protocol allowing the exploration of 14 intercostal spaces. LUT will be timed, recorded and anonymized.\n\nThe operator will note the 3 ultrasound signs (total number of B lines, pleural line thickening and percentage of pleural line irregularity), their location and severity.\n\nThe radiologist, on his part, will evaluate the patient's chest CT (gold standard), blinded to the results of the LUS, to make or not the diagnosis of RA-ILD."}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"37000", "city"=>"Tours", "country"=>"France", "contacts"=>[{"name"=>"Sylvie LEGUE", "role"=>"CONTACT", "email"=>"s.legue@chu-tours.fr", "phone"=>"247479835", "phoneExt"=>"+33"}, {"name"=>"Ariane MERLIN-DOMONT", "role"=>"CONTACT", "email"=>"x.ariane.md@gmail.com"}], "facility"=>"university hospital Tours", "geoPoint"=>{"lat"=>47.38333, "lon"=>0.68333}}], "centralContacts"=>[{"name"=>"Sylvie LEGUE", "role"=>"CONTACT", "email"=>"s.legue@chu-tours.fr", "phone"=>"0247479835", "phoneExt"=>"+33"}, {"name"=>"Ariane MERLIN-DOMONT", "role"=>"CONTACT", "email"=>"x.ariane.md@gmail.com", "phoneExt"=>"+33"}], "overallOfficials"=>[{"name"=>"Sylvie LEGUE", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"University Hospital, Tours"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"UNDECIDED"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"University Hospital, Tours", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
