SilicosisNCT05546944
The SHIELD Study-silicosis
An observational study of Silicosis, run by The University of Queensland at 1 site in Australia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Silicosis
- How many people
- 120 participants
- Where
- 1 siteAustralia
- Study dates
- 16 Aug 2022to Dec 2024
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Respirable crystalline silica (RCS) exposed workers with silicosis or silica induced bronchitis
Who may be able to join
- All workers with a history of significant engineered stone exposure will be potentially eligible.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Australia1 site, 1 recruiting
- Recruiting
The Prince Charles Hospital
Brisbane, Queensland
Daniel Chambers, 736467498, daniel.chambers@health.qld.gov.au
About this study
Official title: Silicosis-harnessing New Ideas to Conquer the Re-emergence of an Ancient Lung Disease
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
- Conditions
- Silicosis
- Keywords
- Silicosis, Pneumoconiosis, lung diseases
- Medical subject headings
- Silicosis, Pneumoconiosis, Lung Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2022
- Study start16 Aug 2022
- Primary completionJun 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SilicosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 120 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- The University of Queensland
- Sponsor type
- University, hospital or other
- Collaborators
- The Prince Charles Hospital, Royal Prince Alfred Hospital, Sydney, Australia, The Alfred, Austin Hospital, Melbourne Australia
- Responsible party
- Sponsor
- Investigators
- Daniel Chambers, Principal investigator, The Prince Charles Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05546944
- Sponsor's protocol ID
- SHIELD
- Status last verified
- Mar 2022
- First submitted
- 15 Sep 2022
- Last updated
- 21 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Silicosis-harnessing New Ideas to Conquer the Re-emergence of an Ancient Lung Disease
- ClinicalTrials.gov ID
- NCT05546944
- Acronym / sponsor ID
- SHIELD
- Conditions
- Silicosis
- Keywords
- Silicosis, Pneumoconiosis, lung diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- The University of QueenslandUniversity, hospital or other
- Collaborators
- The Prince Charles Hospital, Royal Prince Alfred Hospital, Sydney, Australia, The Alfred, Austin Hospital, Melbourne Australia
- Study start
- 16 Aug 2022 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 21 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Respirable crystalline silica (RCS) exposed workers with silicosis or silica induced bronchitis
Key inclusion criteria (1 listed)
- All workers with a history of significant engineered stone exposure will be potentially eligible.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Chambers principal investigator
The Prince Charles Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Silicosis, run by The University of Queensland at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Daniel Chambers ((07) 3646 7498, daniel.chambers@health.qld.gov.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2022.