Pulmonary Disease Among Patients With Systemic Lupus Erythematosus

NCT06087523 | Unknown DMC

• 1 other identifier: OP_1858
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Pulmonary diseases are common among patients with Systemic Lupus Erythematosus (SLE) and associated with a significantly increased morbidity, mortality, and lower self-reported health related quality of life. The investigators aim to diagnose and categorise SLE patients in regards of pulmonary disease and introduce alternative diagnostic tools. The investigators will perform a cross-sectional study of a population-based study population of SLE patients. The participants will undergo review of medical record, a clinical assessment, body plethysmography, six-minute walk test, high-resolution computed tomography of the thorax (HRCT), thoracic and diaphragmatic ultrasound, blood sampling with analysis of autoantibodies, and three questionnaires. After the investigations, pulmonary diseases among the participants will be diagnosed at a multidisciplinary discussion by a specialised pulmonologist with contribution from a rheumatologist and a radiologist. The investigators believe that the study will increase the understanding of pulmonary diseases among SLE patients, which could improve overall disease management. The investigators will introduce new alternative diagnostic tools, that could ease diagnosing pulmonary disease among SLE.

Conditions

Lupus Erythematosus, Systemic; Pulmonary Disease

Keywords

Lupus Erythematosus, Systemic; Pulmonary Disease; Ultrasonography; Autoantibodies; Patient Reported Outcome Measures; Respiratory Function Tests; Tomography, Spiral Computed

Outcome Measures

Primary Outcomes (1)

• Diagnosis of pulmonary diseases

  Participants will be diagnosed and categorised in regards of pulmonary disease at a multidisciplinary discussion the investigators will note following pulmonary diseases: * Pleural disease * Airway disease * ILD * Shrinking lung syndrome * Vascular Disease * Malignancy The diagnosis will be associated to PFT, PROMs, and HRCT. PFT: * Body plethysmography * Lung diffusion testing * Six-minutes walk test. HRCT, note presence of * ILD * Airway disease * Pleural disease * Vascular disease PROMs: * Saint George's Respiratory Questionnaire Interstitial Pulmonary Fibrosis (SGRQi) * Systemic Lupus Activity Questionnaire (SLAQ) * Lupus Impact Tracker (LIT)

  From visit date to diagnose is noted, up to six weeks

Secondary Outcomes (1)

• Ability of alternative diagnostic tools for diagnosis of pulmonary disease in patients with SLE as compared to gold standard

  Thoracic ultrasound, diaphragmatic ultrasound, clinical investigations of patients, PFT, HRCT and PROMs are noted with a month after the visit.

Interventions

Multidisciplinary discussion OTHER

Multidisciplinary discussion: Participants will be diagnosed and categorized in regards of pulmonary disease on basis of medical record, PFT, HRCT, and questionnaires. PFT: Participants will undergo body plethysmography (with diffusion) and six-minute walk test. Analysis of circulating biomarkers: We will store glasses with serum and glasses with plasma and analyse them for circulating biomarker. Questionnaires: Participants will complete Danish versions of three questionnaires. * Saint George's Respiratory Questionnaire Interstitial Pulmonary Fibrosis * Systemic Lupus Activity Questionnaire * Lupus Impact Tracker Review of medical record and clinical investigation with focus on SLE and pulmonary disease. Thoracic and diaphragmatic ultrasound: The participants will undergo a 14 zone protocol, and be evaluated for b-lines and pleural thickening/irregularities. Diaphragm function will be evaluated according to the M-mode method, area method, and for thickening.

Also known as: Thoracic and diaphragmatic ultrasound, High resolution CT scan of thorax (HRCT), Pulmonary function testing (PFT), Analysis of circulating biomarkers, Questionnaires (PROMs), Review of medical record., Clinical investigation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients with Systemic Lupus Erythematosus, in Region Southern Denmark (approximately 300 individuals)

You may qualify if:

• Followed at a Department of Rheumatology in Region Southern Denmark.
• Living in Region Southern Denmark.
• Diagnosed with Systemic Lupus Erythematosus.
• Fulfil the 2019 European League Against Rheumatism / American College of Rheumatology classification criteria.
• Speak and understand spoken and written Danish

You may not qualify if:

• Participants not having their native lungs
• Not participating in visit day, without a valid reason.

Sponsors & Collaborators

• Odense University Hospital: lead
• Karolinska University Hospital: collaborator
• Esbjerg Hospital - University Hospital of Southern Denmark: collaborator
• Vejle Hospital: collaborator
• Sonderborg Hospital: collaborator

Study Sites (1)

Odense University Hospital

Odense, Region Southern Denmark, DK 5000, Denmark

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples, serum and plasma

MeSH Terms

Conditions

Lupus Erythematosus, Systemic; Lung Diseases

Interventions

Respiratory Physiological Phenomena; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Circulatory and Respiratory Physiological Phenomena; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Anne Voss, MD, PhD

  Odense University Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Professor

Study Record Dates

• First Submitted: September 8, 2023
• First Posted: October 17, 2023
• Study Start: August 15, 2023
• Primary Completion: September 30, 2024
• Study Completion: January 1, 2026
• Last Updated: October 17, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)