RecruitingNCT05007340

ILD-SARDs Registry and Biorepository

Interstitial Lung Disease in Systemic Autoimmune Rheumatic Diseases (ILD-SARDs) Registry and Biorepository

Sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Enrollment

252 participants

Start Date

Aug 24, 2021

Study Type

OBSERVATIONAL

Conditions

Interstitial Lung Disease Rheumatic Arthritis Systemic Lupus Erythematosus Systemic Sclerosis Rheumatic Diseases Systemic Autoimmune Disease Autoimmune Myositis Usual Interstitial Pneumonia Nonspecific Interstitial Pneumonia

Summary

A complex interaction between demographic, environmental and genetic mechanisms impact the onset, severity and outcome of ILD-SARDs through dysregulation of the immune system and lung pro-biotic pathways. Comorbidity and genetic risk indicate that there are overlapping pathogenic mechanisms among SARDs, some of which underlie ILD in different SARDs. The purpose of this biobank is to study the clinical, pathological, laboratory, and imaging characteristics of SARDs patients with lung involvement. This will help identify as unique features underlying lung involvement in SARDs. In addition, this may lead to the discovery of novel mechanisms of disease and potentially novel targets of treatment for SARDs patients with lung disease.

Eligibility

Min Age: 18 Years

Inclusion Criteria4

Must be aged 18 years or older
Diagnosis of ILD as confirmed by a chest CT
Either a defined SARD, an undifferentiated connective tissue disease or features of autoimmunity without meeting clinical criteria for SARD
Patient must be willing to give their informed consent and must be able to understand and follow the required study procedures.

Exclusion Criteria1

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Interventions

OTHERBlood draws

Blood draws will be performed by personnel that are both qualified and authorized by their employer/institution to perform the procedures. The procedures will be performed with standards expected in the context of clinical care. 40 mL (2-3 tbsp) of blood will be drawn in order to collect DNA, RNA, serum and PBMCs. Blood tubes will be sent to the Bank as per the SOP for patient blood sampling and processing. The blood will be processed, centrifuged and stored by a trained laboratory technician.

OTHEROther biological samples to biobank (skin, lung and muscle biopsies; bronchoalveolar lavage (BAL fluid)

If the patient's medical care or their participation in a research project involves a biopsy or surgery to remove tissue, the tissue not required for diagnosis (excess tissue) or hospital archives will be included in the biobank. This may include healthy tissue as well as tissue affected by the patient's health condition. The Investigators will not conduct extra procedures in order to obtain samples for the sole purpose of this study and will only operate on what's available. These may include blood samples, skin, lung and muscle biopsies, and bronchoalveolar lavage, all of which will be obtained from the pathology department.

OTHERClinical data collection

Participant's relevant medical information from medical records, general health questionnaires and clinical assessments. The data includes gender, date of birth, race/ethnicity, habits, height, weight, vital signs, medical history, family history, pregnancy history, imaging data pertinent to ILDs and SARDs, results of routine blood tests, environmental exposures, medication and treatment exposures and adherence, function and quality of life, patient's assessment of their own health, clinical symptoms.

OTHERGenetic data/DNA/RNA

Results of the DNA or RNA sequencing, conducted for the Biobank and will be made available to future research; possible single nucleotide polymorphism (SNP) assays (including single SNP, low-plex or microarray-based assays).