RecruitingNot Applicable

ILD-SARDs Registry and Biorepository

Canada252 participantsStarted 2021-08-24

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.

What they're measuring

Rate of death or lung transplant via Connective Tissue Disease (CTD) ILD Physician Baseline Respirology Only Form, and CTD ILD Physician Follow-Up Form

Timeframe: 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

Timeframe: 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

Timeframe: 5 years

Rate of reasons for worsening symptoms via CTD ILD Physician Baseline Respirology Only Form, and ILD-SARDs Additional AcuteSubacute Respiratory Worsening Form

Timeframe: 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

Timeframe: 5 years

Patient Global Assessment Questionnaire

Timeframe: 5 years

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

Trial details

NCT IDNCT05007340

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

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-08

Contact for this trial

Deborah Assayag, MD, MAS

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

View on ClinicalTrials.gov More Interstitial Lung Disease trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.

What they're measuring

Rate of death or lung transplant via Connective Tissue Disease (CTD) ILD Physician Baseline Respirology Only Form, and CTD ILD Physician Follow-Up Form

Timeframe: 5 years

Rate of reasons for worsening symptoms via CTD ILD Physician Baseline Respirology Only Form, and ILD-SARDs Additional AcuteSubacute Respiratory Worsening Form

Timeframe: 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

Timeframe: 5 years

Patient Global Assessment Questionnaire

Timeframe: 5 years

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