SilicosisSHIELDNCT05402176
The SHIELD Whole Lung Lavage Study
An observational study of Silicosis, run by The University of Queensland at 4 sites in Australia.
Trial summary
An observational cohort study that will assess the efficacy of Whole Lung Lavage in workers with silicosis or silica-induced bronchitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Silicosis
- What is being tested?
- Whole Lung Lavage
- How many people
- 30 participants
- Where
- 4 sitesAustralia
- Study dates
- Jun 2022to Dec 2024
- 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
- Males and females aged >=18 years and scheduled for WLL at the study site as part of routine clinical care
- History of exposure to respirable crystalline silica (RCS) while working in an at-risk industry (e.g. stonemasonry, construction, tunnelling, concreting, mining)
- Elimination of workplace exposure to RCS for a minimum of 6 months
- Ground glass nodularity > extent of solid nodularity on HRCT, as judged by investigator or evidence of silica-induced bronchitis
- Evidence of disease progression within the past 2 years, defined as any of
- a relative decline in the FVC or FEV1 of at least 5% of the predicted value,
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- worsening of respiratory symptoms
- increased extent of silicosis on high-resolution CT scan
- Able to understand and sign a written informed consent form (or legally authorised representative)
Who cannot join
- Ongoing workplace exposure to RCS or removal of workplace exposure of less than 6 months
- Progressive massive fibrosis, defined as areas of confluent fibrosis with diameter > 10mm on HRCT.
- FEV1 or FVC < 50% predicted
- DLCO <50% predicted
- Contraindication to WLL, as judged by the investigator
- Actively or imminently listed for lung transplantation
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- Females with a positive pregnancy test at screening or currently breastfeeding
- Any history of malignancy likely to result in significant disability or likely to require significant medical or surgical intervention within the next 24 months
- Any condition other than silicosis that, in the opinion of the investigator, is likely to result in the death of the participant within the next 24 months
- Significantly impaired cardiac function
Trial locations and contacts
4 sites in 1 country.
Australia4 sites
The Prince Charles Hospital
Brisbane, Queensland
The Alfred Hospital
Melbourne, Victoria
The Austin Hospital
Melbourne, Victoria
The Royal Prince Alfred Hospital
Sydney, New South Wales
About this study
Official title: Silicosis - Harnessing New Ideas to Conquer the Re-emergence of an Ancient Lung Disease: The SHIELD Whole Lung Lavage Study
An observational cohort study that will assess the efficacy of Whole Lung Lavage in workers with silicosis or silica-induced bronchitis.
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 determine the effectiveness and safety of Whole Lung Lavage (WLL) in workers with silicosis due to significant engineered stone exposure.
DESIGN: Participants (30) with silicosis or silica-induced bronchitis who are scheduled to undergo WLL as part of their normal care will be enrolled. They will undergo the following interventions pre and 3 months post WLL, some of which would have been carried out as part of routine standard care:
- Complex pulmonary function tests (PFTs) - standard care
- HRCT scan (if not within 6 months of WLL) - standard care
- Blood tests
- Cardiopulmonary exercise testing
- Forced oscillatory technique
- XV Lung Ventilation Analysis
- Questionnaires (K-BILD and LCQ)
- Conditions
- Silicosis
- Being tested
- Whole Lung Lavage
- Medical subject headings
- Silicosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole Lung LavageOther
Whole Lung Lavage (WLL) is performed as standard of care. Outcome following WLL is observed.
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome for evaluating WLL will be change in dual blind read CT ICOERD score from baseline to 3 months post WLL.
Change in absolute dual-read CT ICOERD score at 3 months post-WLL. Data collected will be evaluated by a central reader blinded to treatment assignment. Baseline characteristics will be summarised for each group. Differences between group mean changes in CT ICOERD scores from baseline to 3 months will be tested using an independent sample t-test.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2022
- Study startJun 2022 (estimated)
- 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Queensland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel Chambers, Principal investigator, The Prince Charles Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05402176
- Sponsor's protocol ID
- SHIELD WLL
- Acronym
- SHIELD
- Status last verified
- May 2022
- First submitted
- 23 May 2022
- Last updated
- 2 Jun 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 2 Jun 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: The SHIELD Whole Lung Lavage Study
- ClinicalTrials.gov ID
- NCT05402176
- Acronym / sponsor ID
- SHIELD / SHIELD WLL
- Conditions
- Silicosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- The University of QueenslandUniversity, hospital or other
- Study start
- Jun 2022 (estimated)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 2 Jun 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 that will assess the efficacy of Whole Lung Lavage in workers with silicosis or silica-induced bronchitis.
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 determine the effectiveness and safety of Whole Lung Lavage (WLL) in workers with silicosis due to significant engineered stone exposure.
DESIGN: Participants (30) with silicosis or silica-induced bronchitis who are scheduled to undergo WLL as part of their normal care will be enrolled. They will undergo the following interventions pre and 3 months post WLL, some of which would have been carried out as part of routine standard care:
- Complex pulmonary function tests (PFTs) - standard care
- HRCT scan (if not within 6 months of WLL) - standard care
- Blood tests
- Cardiopulmonary exercise testing
- Forced oscillatory technique
- XV Lung Ventilation Analysis
- Questionnaires (K-BILD and LCQ)
Study design
- Observational model
- Cohort
- Time perspective
- Other
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 (9 listed)
- Males and females aged >=18 years and scheduled for WLL at the study site as part of routine clinical care
- History of exposure to respirable crystalline silica (RCS) while working in an at-risk industry (e.g. stonemasonry, construction, tunnelling, concreting, mining)
- Elimination of workplace exposure to RCS for a minimum of 6 months
- Ground glass nodularity > extent of solid nodularity on HRCT, as judged by investigator or evidence of silica-induced bronchitis
- Evidence of disease progression within the past 2 years, defined as any of
Key exclusion criteria (10 listed)
- Ongoing workplace exposure to RCS or removal of workplace exposure of less than 6 months
- Progressive massive fibrosis, defined as areas of confluent fibrosis with diameter > 10mm on HRCT.
- FEV1 or FVC < 50% predicted
- DLCO <50% predicted
- Contraindication to WLL, as judged by the investigator
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whole Lung LavageWhole Lung Lavage (WLL) is performed as standard of care. Outcome following WLL is observed. | Other | – |
Primary outcome
The primary outcome for evaluating WLL will be change in dual blind read CT ICOERD score from baseline to 3 months post WLL.
Time frame: 3 months
Change in absolute dual-read CT ICOERD score at 3 months post-WLL. Data collected will be evaluated by a central reader blinded to treatment assignment. Baseline characteristics will be summarised for each group. Differences between group mean changes in CT ICOERD scores from baseline to 3 months will be tested using an independent sample t-test.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2022.
Related trials for Silicosis
Not yet recruitingObservational study
Perioperative Risk Factors Related to the Prognosis of Lung Transplantation: A Retrospective Study
COPD, Interstitial Pneumonia
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
4 sites 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 4 sites 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 9 inclusion and 10 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 2 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 primary outcome for evaluating WLL will be change in dual blind read CT ICOERD score from baseline to 3 months post WLL. (time frame: 3 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 2 Jun 2022.