Identifying Unique Pathogenic Macrophages in Systemic Sclerosis-ILD

NCT03438032 | Completed

• 1 other identifier: SP0044402
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Alveolar macrophages isolated from bronchoalveolar lavage (BAL) fluid from systemic sclerosis (SSc) patients with clinically significant lung fibrosis will be studied at baseline and at 6 months after enrollment to assess longitudinally the presence and persistence of an emergent, pro-fibrotic alveolar macrophage population, using single cell RNA-Seq technology to measure the individual transcriptome from each cell.

Conditions

Fibrosis Lung; Systemic Sclerosis

Outcome Measures

Primary Outcomes (1)

• Single-cell RNA-seq analysis

  Change in alveolar macrophage transcriptome at 6 months, as measured by single cell RNA-sequencing

  Baseline and 6 months

Study Arms (2)

SSc-ILD

SSc-ILD subjects will be defined by those who fulfill 2013 American College of Rheumatology SSc criteria and have forearm modified Rodnan skin scores (mRSS) ≥1 (a validated, semi-quantitative scoring system for dermal fibrosis) and clinically relevant SSc-interstitial lung disease (ILD). A subject will be defined as having ILD if they have radiographic evidence for ILD and a forced vital capacity \<70% on pulmonary function test (PFT).

Diagnostic Test: Bronchoscopy with lavage

Control

Healthy control subjects recruited from the Northwestern community will complete demographic and basic medical forms to ensure health

Diagnostic Test: Bronchoscopy with lavage

Interventions

Bronchoscopy with lavage DIAGNOSTIC_TEST

During an elective bronchoscopy procedure, the bronchoscope will be wedged into an affected lung segment guided by CT scanning. When involved an anterior segment will be used to maximize return. After wedging the bronchoscope, 120ml of sterile 0.09% normal saline will be instilled. Up to 40-60 mL of BAL fluid will be obtained for analysis during each sampling.

Control; SSc-ILD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Subjects with SSc-ILD will be recruited from the Northwestern University Scleroderma Program. Healthy control subjects recruited from the Northwestern community.

You may qualify if:

• meet 2013 ACR criteria for diagnosis of SSc
• have radiographic evidence for ILD and a forced vital capacity \<70% on PFT
• have not taken immune suppression in the last 2 months OR have taken a stable dose of mycophenolate mofetil, rituximab, or prednisone less than or equal to 10 mg for at least 6 months

You may not qualify if:

• diagnosis of an overlap syndrome, such as lupus or rheumatoid arthritis
• unable to provide informed consent in English
• currently pregnant or nursing
• current smoker or former smoker (greater than 10 pack years)
• leukopenia
• anemia
• comorbidities of uncontrolled congestive heart failure, cancer not in remission, HIV, or chronic liver disease
• known or suspected infection in the past 3 months
• BMI greater than or equal to 30 kg/m2

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Pulmonary Fibrosis; Scleroderma, Systemic

Interventions

Bronchoscopy

Condition Hierarchy (Ancestors)

Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Pulmonary Surgical Procedures; Thoracic Surgical Procedures

Study Officials

• Cara Gottardi, PhD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: February 12, 2018
• First Posted: February 19, 2018
• Study Start: June 28, 2018
• Primary Completion: October 12, 2022
• Study Completion: March 8, 2024
• Last Updated: November 14, 2024

Record last verified: 2024-11

Locations

US (1)