ILD-SARDs Registry and Biorepository

NCT05007340 | Recruiting

• 1 other identifier: 2021-7678
• Study Type: observational
• Target: 252
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

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

Outcome Measures

Primary Outcomes (11)

• 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)

  5 years

• 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)

  5 years

• 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

  5 years

• 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

  5 years

• Rate of outcome of acute exacerbations and hospitalizations via CTD ILD Physician Baseline Respirology Only Form, and ILD-SARDs Additional AcuteSubacute Respiratory Worsening Form

  Evaluation of outcome of acute exacerbations and hospitalizations between resolved, plateau with worse symptoms and death

  5 years

• Patient Global Assessment Questionnaire

  To measure quality of life and patient related outcomes, ranging from 0 to 10, and where higher scores mean a worse outcome.

  5 years

• 36-Item Short Form Survey (SF-36 v2)

  To measure quality of life, ranging from 1 to 3 or 5 depending on the question, and where higher scores can either mean a better or worse outcome, depending on the question.

  5 years

• University of California San Diego Medical Center Pulmonary Rehabilitation Program Shortness-of-Breath Questionnaire (UCSD SOBQ)

  To measure patient-related outcomes, specifically with dyspnea, ranging from 0 to 5, where higher scores mean a worse outcome.

  5 years

• Functional Assessment of Chronic Illness Therapy - Dyspnea (FACIT-Dyspnea) Questionnaire

  To measure patient-related outcomes, specifically with dyspnea, ranging from "No shortness of breath" to "Severely short of breath", including "I did not do this in the past 7 days" with possibility to indicate reason why.

  5 years

• Patient-Reported Outcomes Measurement Information System 29 (PROMIS-29) Questionnaire

  To measure patient-related outcomes, specifically with dyspnea, ranging from 1 to 5, where higher scores can mean a better or worse outcome, depending on the question.

  5 years

• King's Brief Interstitial Lung Disease (KBILD) Questionnaire

  To measure patient-related outcomes, specifically with dyspnea, ranging from 1 to 7, where higher scores mean a better outcome.

  5 years

Interventions

Blood draws OTHER

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

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.

Clinical data collection OTHER

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.

Genetic data/DNA/RNA OTHER

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).

Eligibility Criteria

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

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• N/A

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead
• McGill University: collaborator

Study Sites (1)

RI-MUHC

Montreal, Quebec, H3G 1A4, Canada

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

* Blood draws: 40 mL (2-3 tbsp) of blood will be drawn in order to collect DNA, RNA, serum and peripheral blood mononuclear cella (PBMCs). * For any other tissues or samples: 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.

MeSH Terms

Conditions

Lung Diseases, Interstitial; Rheumatic Diseases; Rheumatic Fever; Scleroderma, Systemic; Lupus Erythematosus, Systemic; Idiopathic Pulmonary Fibrosis

Interventions

Blood Specimen Collection; Bronchoalveolar Lavage

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Musculoskeletal Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Arthritis; Joint Diseases; Skin Diseases; Autoimmune Diseases; Immune System Diseases; Pulmonary Fibrosis

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Therapeutic Irrigation

Study Officials

• Christian Pineau, MD

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

  PRINCIPAL INVESTIGATOR

• Inés Colmegna, MD

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

  PRINCIPAL INVESTIGATOR

• Silvia Vidal, PhD

  McGill University/Research Institute of the McGill University Health Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Deborah Assayag, MD, MAS

CONTACT

514-934-1934; deborah.assayag@mcgill.ca

Victoria Nam-Amnath, RN, BScN

CONTACT

514-934-1934; victoria.nam-amnath@muhc.mcgill.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, MD, MAS

Study Record Dates

• First Submitted: July 29, 2021
• First Posted: August 16, 2021
• Study Start: August 24, 2021
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: September 9, 2021

Record last verified: 2021-09

Locations

CA (1)