Ignite Creation Date:
2025-12-24 @ 3:28 PM
Ignite Modification Date:
2025-12-24 @ 3:28 PM
Study NCT ID:
NCT04474392
Status:
UNKNOWN
Last Update Posted:
2022-06-14
First Post:
2020-06-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Sputum Studies of Anti-Citrullinated Protein Antibodies (ACPA) and Rheumatoid Arthritis (RA) Origins
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019370', 'term': 'Observation'}], 'ancestors': [{'id': 'D008722', 'term': 'Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood, saliva, and sputum samples are collected for this study. The blood, saliva, and sputum samples are stored in -80 freezers at the Barbara Davis Center.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 340}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2025-07-14', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-06-13', 'studyFirstSubmitDate': '2020-06-29', 'studyFirstSubmitQcDate': '2020-07-15', 'lastUpdatePostDateStruct': {'date': '2022-06-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-14', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sputum anti-CCP antibodies predicting incident RA', 'timeFrame': '1-3 years per participant (depending on group); study visits x1 per year, with option for 3 additional visits over 1 year for a subgroup of participants.', 'description': '\\*Sputum anti-CCP antibodies every year for 3 years (subjects At-Risk for RA); to identify whether sputum anti-CCP predicts incident RA'}], 'secondaryOutcomes': [{'measure': 'Effect of inflammatory cytokines on the induction of NETosis in sputum neutrophils', 'timeFrame': '1-3 yrs / participant; At-Risk Group: Baseline Visit & 2 Follow-up Annual Visits (w/ potential to have 3 additional visits in 1 year); Healthy Controls & RA Diagnosed: Baseline Visit & 1 Follow-up Visit, approximately 1 year later', 'description': '\\*Determine the effect of inflammatory cytokines on the induction of NETosis in sputum neutrophils'}, {'measure': 'The role of sputum macrophage phagocytosis in NET clearance', 'timeFrame': '1-3 years / participant; At-Risk Group: Baseline Visit & 2 Follow-up Annual Visits (w/ potential to have 3 additional visits in 1 year); Healthy Controls & RA Diagnosed: Baseline Visit & 1 Follow-up Visit, approximately 1 year later', 'description': '\\*Determine the role of sputum macrophage phagocytosis in NET clearance among At-Risk, healthy, \\& RA subjects'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Rheumatoid Arthritis']}, 'referencesModule': {'references': [{'pmid': '18383413', 'type': 'BACKGROUND', 'citation': 'Allaire S, Wolfe F, Niu J, Lavalley MP. 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Impaired deoxyribonuclease I activity in patients with inflammatory bowel diseases. Autoimmune Dis. 2011;2011:945861. doi: 10.4061/2011/945861. Epub 2011 May 29.'}]}, 'descriptionModule': {'briefSummary': 'The study is designed to learn more about the causes of rheumatoid arthritis (RA). People who get RA have elevated protein markers called autoantibodies in their blood years before initial symptoms of arthritis. The goal of this study is to learn more about how autoantibodies in RA might be related to inflammation in the lungs.', 'detailedDescription': "The Specific Aims of This Study Are As Follows:\n\n1. Identify whether sputum anti-CCP predicts incident RA\n2. Determine the effect of inflammatory cytokines on the induction of NETosis in sputum neutrophils\n3. Determine the role of sputum macrophage phagocytosis in NET clearance \\<br\\> The knowledge gained from this study will improve the overall understanding of the development of RA. It is anticipated that these findings will improve the field's understanding of how best to screen for RA risk and target RA prevention. This study could support future lung-targeted prevention strategies for RA that could avoid the administration of systemic toxic therapies. Such potential prevention interventions could be implemented in subjects at risk for RA in order to prevent the irreversible joint damage that can occur in the later stages of clinically-apparent RA."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'We will recruit subjects from 1) the Denver site of the SERA project (COMIRB #01-0675); 2) local rheumatology clinics, including the University of Colorado Hospital (UCH), Denver Health, National Jewish Health (NJH), and the Denver Arthritis Clinic; 3) local health clinics at UCH; and 4) local advertisements.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults between 18 and 100 years;\n* At-Risk for RA, RA diagnosed, and Healthy Control subjects will be included in the study until recruitment goals are met for each group.\n\nAt-Risk:\n\n1. No evidence of inflammatory arthritis on clinical examination AND\n2. At elevated risk for RA based on familial or serologic risk\n\n * Familial risk includes having a first degree relatives (FDRs) with RA\n * Serologic risk includes asymptomatic serum ACPA positivity\n\nHealthy Controls :\n\n1. No history of RA\n2. No FDRs with RA\n3. No systemic use of immunosuppressants for autoimmune disease\n\nRA Diagnosis:\n\n1. Classified RA by 1987 ACR and/or 2010 ACR/EULAR RA classification criteria (confirmed by medical chart review) OR\n2. Diagnosed with RA by a board-certified rheumatologist (confirmed by medical chart review)\n\nExclusion Criteria:\n\n1. Currently pregnant or planning to become pregnant during the sample collection period of the study\n2. Exacerbation of underlying obstructive lung disease within the past 1 month\n3. Known FEV1 \\<1 liter\n4. Oxygen requirement \\>2 liters at rest\n5. Participants with health acuity or behavioral health concerns leaving them unable to participate in the current research\n\nNote: If a subject temporarily does not meet inclusion criteria but is interested in participating, he/she may participate once inclusion criteria have been met.\n\nIf interested, please take a few minutes to complete the screening questionnaire for this study opportunity. You may open the survey in your web browser by clicking the link below:\n\nhttps://is.gd/SPAROscreen\n\nIf the link above does not work, try copying the link below into your web browser:\n\nhttps://redcap.ucdenver.edu/surveys/?s=3WM8WH3WKK'}, 'identificationModule': {'nctId': 'NCT04474392', 'acronym': 'SPARO', 'briefTitle': 'Sputum Studies of Anti-Citrullinated Protein Antibodies (ACPA) and Rheumatoid Arthritis (RA) Origins', 'organization': {'class': 'OTHER', 'fullName': 'University of Colorado, Denver'}, 'officialTitle': 'Sputum Studies of Anti-Citrullinated Protein Antibodies (ACPA) and Rheumatoid Arthritis (RA) Origins', 'orgStudyIdInfo': {'id': '20-0206'}, 'secondaryIdInfos': [{'id': '1R01AR076450-01', 'link': 'https://reporter.nih.gov/quickSearch/1R01AR076450-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'At-Risk (N=180)', 'description': "1. No evidence of inflammatory arthritis on clinical examination AND\n2. At elevated risk for RA based on familial or serologic risk\n\n * Familial risk includes having a first degree relatives (FDRs) with RA\n * Serologic risk includes asymptomatic serum ACPA positivity\n\nThere will be 1 study visit per year for 3 years; for a subset of 30 of these participants, there will be an additional 3 quarterly visits in one year.\n\nStudy Procedures (Baseline \\& Follow-up):\n\n* Questionnaires\n* Physical and joint exam\n* Measurement of participants' height, weight\n* Blood and sputum collection", 'interventionNames': ['Other: N/A (Observational Study)']}, {'label': 'Healthy Controls (N=120)', 'description': "1. No history of RA\n2. No FDRs with RA\n3. No systemic use of immunosuppressants for autoimmune disease\n\nParticipants will return for 1 follow-up visit, approximately 1 year after their baseline visit.\n\nStudy Procedures (Baseline \\& Follow-up):\n\n* Questionnaires\n* Physical and joint exam\n* Measurement of participants' height, weight\n* Blood and sputum collection", 'interventionNames': ['Other: N/A (Observational Study)']}, {'label': 'RA Diagnosis (N=40)', 'description': "1. Classified RA by 1987 ACR and/or 2010 ACR/EULAR RA classification criteria (confirmed by medical chart review) OR\n2. Diagnosed with RA by a board-certified rheumatologist (confirmed by medical chart review)\n\nParticipants will return for 1 follow-up visit, approximately 1 year after their baseline visit.\n\nStudy Procedures (Baseline \\& Follow-up):\n\n* Questionnaires\n* Physical and joint exam\n* Measurement of participants' height, weight\n* Blood and sputum collection", 'interventionNames': ['Other: N/A (Observational Study)']}], 'interventions': [{'name': 'N/A (Observational Study)', 'type': 'OTHER', 'description': 'Observational study, no intervention will be administered.', 'armGroupLabels': ['At-Risk (N=180)', 'Healthy Controls (N=120)', 'RA Diagnosis (N=40)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kasey Bales', 'role': 'CONTACT', 'email': 'KASEY.BALES@CUANSCHUTZ.EDU', 'phone': '303-724-0071'}, {'name': 'Kristin Sturm, MA', 'role': 'CONTACT', 'email': 'KRISTIN.STURM@CUANSCHUTZ.EDU', 'phone': '303-724-5658'}, {'name': 'Kristen Demoruelle, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Colorado Denver (Anschutz Medical Campus)', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}], 'centralContacts': [{'name': 'Kasey Bales', 'role': 'CONTACT', 'email': 'KASEY.BALES@CUANSCHUTZ.EDU', 'phone': '303-724-0071'}, {'name': 'Kristin Sturm, MA', 'role': 'CONTACT', 'email': 'KRISTIN.STURM@CUANSCHUTZ.EDU', 'phone': '303-724-5658'}], 'overallOfficials': [{'name': 'Kristen Demoruelle, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Colorado, Denver'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Colorado, Denver', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}, {'name': 'National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}