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.
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.
None
Incident and prevalent ILD-SARDs cases, treatment-naive or non-treatment-naive, followed at the monthly ILD-SARDs clinic at the MUHC will be offered enrollment into this registry at the time when the participants present for their initial or follow-up clinical visit. According to estimations, the Investigators will recruit 252 patients over the initial 5 years. However, the Investigators plan to recruit as many patients as the Investigators can. ILD-SARDs patients identified in the MUHC Pulmonary Clinic or admitted at the MUHC will also be approached and offered enrollment into the registry. Healthy donors that are sex- and relatively aged-matched are welcome for blood draws.
Cohort
Prospective
Blood draws
Other interventionBlood 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 biological samples to biobank (skin, lung and muscle biopsies; bronchoalveolar lavage (BAL fluid)
Other interventionIf 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.
Clinical data collection
Other interventionParticipant'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.
Genetic data/DNA/RNA
Other interventionResults 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).
Rate of death or lung transplant via Connective Tissue Disease (CTD) ILD Physician Baseline Respirology Only Form, and CTD ILD Physician Follow-Up Form
Date and cause of death, date of lung transplantation and type (bilateral, single)
Time to acute exacerbations and hospitalizations via ILD-SARDs Additional AcuteSubacute Respiratory Worsening Form, CTD ILD Physician Baseline Respirology Only Form, and CTD ILD Physician Follow-Up Form
Date of worsening symptoms, admission to hospital required (dates of admission and discharge)
Rate of requirement of interventions during hospital admission via ILD-SARDs Additional AcuteSubacute Respiratory Worsening Form, CTD ILD Physician Baseline Respirology Only Form, and CTD ILD Physician Follow-Up Form
Yes or no questions for required ICU stay, required noninvasive ventilation, required mechanical ventilation, required extracorporeal membrane oxygenation (ECMO), bronchoscopy performed, treatment received
Rate of reasons for worsening symptoms via CTD ILD Physician Baseline Respirology Only Form, and ILD-SARDs Additional AcuteSubacute Respiratory Worsening Form
List of possible reasons for worsening symptoms/exacerbations
Click on the lead sponsor to view all of their trials.
McGill University Health Centre/Research Institute of the McGill University Health Centre
Lead sponsor
McGill University
Collaborator
