The SHIELD Study-silicosis
Silicosis-harnessing New Ideas to Conquer the Re-emergence of an Ancient Lung Disease
1 other identifier
observational
120
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Aug 2022
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 16, 2022
CompletedFirst Submitted
Initial submission to the registry
September 15, 2022
CompletedFirst Posted
Study publicly available on registry
September 21, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2024
CompletedSeptember 21, 2022
March 1, 2022
1.8 years
September 15, 2022
September 15, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
1. Establish the SHIELD cohort and associated lung fluid, tissue and blood biobank from well phenotyped RCS-exposed workers identified via the screening programs. 2. 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. 3. To evaluate associations between baseline characteristics, biomarkers and progression of disease in the full cohort.
12 months
Eligibility Criteria
Respirable crystalline silica (RCS) exposed workers with silicosis or silica induced bronchitis
You may qualify if:
- All workers with a history of significant engineered stone exposure will be potentially eligible.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- The University of Queenslandlead
- The Prince Charles Hospitalcollaborator
- Royal Prince Alfred Hospital, Sydney, Australiacollaborator
- The Alfredcollaborator
- Austin Hospital, Melbourne Australiacollaborator
Study Sites (1)
The Prince Charles Hospital
Brisbane, Queensland, Australia
Biospecimen
Biomarkers (blood ACE and ferritin)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Daniel Chambers
The Prince Charles Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Target Duration
- 12 Months
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 15, 2022
First Posted
September 21, 2022
Study Start
August 16, 2022
Primary Completion
June 1, 2024
Study Completion
December 1, 2024
Last Updated
September 21, 2022
Record last verified: 2022-03