Recruiting

Observational StudyILD-SARDs Registry and Biorepository

Sponsor:

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

Code:

NCT05007340

Conditions

Interstitial Lung Disease

Systemic Autoimmune Disease

Rheumatic Diseases

Rheumatic Arthritis

Systemic Sclerosis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Blood draws

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

Clinical data collection

Genetic data/DNA/RNA

Study Details

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

Study ID

NCT05007340

Start date

Aug 24, 2021

Status verified date

Sep, 2021

Completion date

Aug, 2026

Anticipated

Primary completion date

Aug, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

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

Exclusion Criteria:

N/A

Study Design

Enrollment

252 participants

Anticipated

Interventions and Outcome Measures

Interventions

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 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.

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.

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).

Primary outcome measure

Rate of death or lung transplant via Connective Tissue Disease (CTD) ILD Physician Baseline Respirology Only Form, and CTD ILD Physician Follow-Up Form [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 5 years ]
Rate of reasons for worsening symptoms via CTD ILD Physician Baseline Respirology Only Form, and ILD-SARDs Additional AcuteSubacute Respiratory Worsening Form [ Time Frame: 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 [ Time Frame: 5 years ]
Patient Global Assessment Questionnaire [ Time Frame: 5 years ]
36-Item Short Form Survey (SF-36 v2) [ Time Frame: 5 years ]
University of California San Diego Medical Center Pulmonary Rehabilitation Program Shortness-of-Breath Questionnaire (UCSD SOBQ) [ Time Frame: 5 years ]
Functional Assessment of Chronic Illness Therapy - Dyspnea (FACIT-Dyspnea) Questionnaire [ Time Frame: 5 years ]
Patient-Reported Outcomes Measurement Information System 29 (PROMIS-29) Questionnaire [ Time Frame: 5 years ]
King's Brief Interstitial Lung Disease (KBILD) Questionnaire [ Time Frame: 5 years ]

Central Contacts and Locations

Central contacts

Deborah Assayag, MD, MAS

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

Victoria Nam-Amnath, RN, BScN

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

Locations

RI-MUHC

Recruiting

Montréal, Quebec, Canada, H3G 1A4

Contacts

Deborah Assayag, MD, MAS

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

Victoria Nam-Amnath, RN, BScN

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

Principal Investigator:

Christian Pineau, MD

More Information

Sponsor

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

Last update posted

Sep 9, 2021

Last verified

Sep, 2021

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McGill University Health Centre/Research Institute of the McGill University Health Centre on 2021-09-09.