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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05402176




Registration number
NCT05402176
Ethics application status
Date submitted
23/05/2022
Date registered
2/06/2022
Date last updated
2/06/2022

Titles & IDs
Public title
The SHIELD Whole Lung Lavage Study
Scientific title
Silicosis - Harnessing New Ideas to Conquer the Re-emergence of an Ancient Lung Disease: The SHIELD Whole Lung Lavage Study
Secondary ID [1] 0 0
SHIELD WLL
Universal Trial Number (UTN)
Trial acronym
SHIELD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Silicosis 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Other interventions - Whole Lung Lavage

Other interventions: Whole Lung Lavage
Whole Lung Lavage (WLL) is performed as standard of care. Outcome following WLL is observed.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The primary outcome for evaluating WLL will be change in dual blind read CT ICOERD score from baseline to 3 months post WLL.
Timepoint [1] 0 0
3 months

Eligibility
Key inclusion criteria
* 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,
* 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)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* 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
* 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

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/06/2022
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2024
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
The Royal Prince Alfred Hospital - Sydney
Recruitment hospital [2] 0 0
The Prince Charles Hospital - Brisbane
Recruitment hospital [3] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [4] 0 0
The Austin Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
- Sydney
Recruitment postcode(s) [2] 0 0
- Brisbane
Recruitment postcode(s) [3] 0 0
- Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
The University of Queensland
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
An observational cohort study that will assess the efficacy of Whole Lung Lavage in workers with silicosis or silica-induced bronchitis.
Trial website
https://clinicaltrials.gov/study/NCT05402176
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Daniel Chambers
Address 0 0
The Prince Charles Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Daniel Chambers
Address 0 0
Country 0 0
Phone 0 0
(07) 3646 7498
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05402176