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Status unknownNCT05546944Updated Sep 21, 2022

The SHIELD Study-silicosis

An observational study in Silicosis, sponsored by The University of Queensland. Status unknown at 1 site in Australia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-09-21.

Sponsored by The University of Queensland · Observational

The sponsor has not verified this record recently (last verified Mar 2022), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
120
Ages
18 Years and older
Sex
All
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Study 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.

Read the detailed 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

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Conditions studied

  • Silicosis

Keywords

  • Silicosis
  • Pneumoconiosis
  • lung diseases
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In context

Silicosis

20 studies on the registry are indexed under Silicosis; 3 are open to participants now.

This study's planned enrollment of 120 is below the median of 150 across 11 observational studies indexed under Silicosis.

Browse Silicosis studies →

Lead sponsor

The University of Queensland is the lead sponsor of 91 studies on the registry; 24 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Respirable crystalline silica (RCS) exposed workers with silicosis or silica induced bronchitis

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

-

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Study design

Observational model
Cohort
Time perspective
Other
Enrollment
120 participants (estimated)
Target follow-up
12 Months
Patient registry
Yes
Biospecimen retention
Samples without dna
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What researchers measure

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.

    Time frame: 12 months

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Study locations

1 of 1 sites recruiting
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 21, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05546944
Lead sponsor
The University of Queensland
Collaborators
The Prince Charles Hospital, Royal Prince Alfred Hospital, Sydney, Australia, The Alfred, Austin Hospital, Melbourne Australia
Responsible party
Sponsor
First posted
Sep 21, 2022
Start date
Aug 16, 2022
Primary completion
Jun 2024 (estimated)
Completion
Dec 2024 (estimated)
Last update
Sep 21, 2022

Study contacts

Daniel Chambers
Contact
daniel.chambers@health.qld.gov.au
(07) 3646 7498
Vidya Navaratnam
Contact
Vidya.Navaratnam@health.qld.gov.au
(07) 3139 4000
Daniel Chambers
principal investigator · The Prince Charles Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

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