ILD-SARDs Registry and Biorepository
NCT05007340 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 252
Last updated 2021-09-09
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.
Conditions
- Interstitial Lung Disease
- Systemic Autoimmune Disease
- Rheumatic Diseases
- Rheumatic Arthritis
- Systemic Sclerosis
- Autoimmune Myositis
- Systemic Lupus Erythematosus
- Usual Interstitial Pneumonia
- Nonspecific Interstitial Pneumonia
Interventions
- OTHER
-
Blood 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.
- OTHER
-
Other 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.
- OTHER
-
Clinical 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.
- OTHER
-
Genetic 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).
Sponsors & Collaborators
-
McGill University Health Centre/Research Institute of the McGill University Health Centre
lead OTHER - collaborator OTHER
Principal Investigators
-
Christian Pineau, MD · McGill University Health Centre/Research Institute of the McGill University Health Centre
-
Inés Colmegna, MD · McGill University Health Centre/Research Institute of the McGill University Health Centre
-
Silvia Vidal, PhD · McGill University/Research Institute of the McGill University Health Centre
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2021-08-24
- Primary Completion
- 2026-08-31
- Completion
- 2026-08-31
Countries
- Canada
Study Locations
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