The SHIELD Study-silicosis

Silicosis Clinical Trial

Official title:

Silicosis-harnessing New Ideas to Conquer the Re-emergence of an Ancient Lung Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05546944
• Other study ID #: SHIELD
• Status: Recruiting
• Start date: August 16, 2022
• Est. completion date: December 2024

Study information

• Verified date: March 2022
• Source: The University of Queensland
• Contact: Daniel Chambers
• Phone: (07) 3646 7498
• Email: daniel.chambers[@]health.qld.gov.au
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

An observational cohort study to derive biomarkers which are able to more accurately diagnose silicosis, as well as predict disease progression, assess response to treatment, and hasten therapeutic discovery.

Description:

Background: Silicosis is a fatal lung disease caused by inhaling silica particles. Australia is currently facing an epidemic with hundreds of young workers having contracted silicosis from machining engineered stone. AIMS: To establish the SHIELD COHORT and associated SHIELD BIOBANK to drive further discovery including assessing the efficacy of whole lung lavage for accelerated silicosis, uncovering disease biomarkers, and druggable targets.

PARTICIPANTS: 75 participants who are respirable crystalline silica exposed workers, (this includes n=30 with silicosis, n=15 with progressive massive fibrosis and n=30 with no pneumoconiosis). METHODS: Advanced microscopy, 'omic platforms and single cell RNA sequencing. OUTCOME: The SHIELD study builds on the knowledge gap to accurately diagnose silicosis, as well as predict disease progression, assess response to treatment, and hasten therapeutic discovery

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All workers with a history of significant engineered stone exposure will be potentially eligible.

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Silicosis

Locations

Country	Name	City	State
Australia	The Prince Charles Hospital	Brisbane	Queensland

Sponsors (5)

Lead Sponsor	Collaborator
The University of Queensland	Austin Hospital, Melbourne Australia, Royal Prince Alfred Hospital, Sydney, Australia, The Alfred, The Prince Charles Hospital

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the SHIELD study primary outcome is to build up knowledge gap to accurately diagnose silicosis, as well as predict disease progress, assess response to treatment, hasten therapeutic discovery in 12 months.	Establish the SHIELD cohort and associated lung fluid, tissue and blood biobank from well phenotyped RCS-exposed workers identified via the screening programs.; Utilise advanced microscopy, 'omic platforms and single cell RNA sequencing (scRNAseq) alongside conventional laboratory techniques, to identify and validate candidate lung and blood biomarkers associated with disease and disease progression at 12 months.; To evaluate associations between baseline characteristics, biomarkers and progression of disease in the full cohort.	12 months