The SHIELD Study-silicosis

NCT ID: NCT05546944

Last Updated: 2022-09-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-08-16

Study Completion Date

2024-12-31

Brief Summary

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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

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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

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Silicosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Prince Charles Hospital

OTHER_GOV

Sponsor Role collaborator

Royal Prince Alfred Hospital, Sydney, Australia

OTHER

Sponsor Role collaborator

The Alfred

OTHER

Sponsor Role collaborator

Austin Hospital, Melbourne Australia

OTHER

Sponsor Role collaborator

The University of Queensland

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Daniel Chambers

Role: PRINCIPAL_INVESTIGATOR

The Prince Charles Hospital

Locations

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The Prince Charles Hospital

Brisbane, Queensland, Australia

Site Status RECRUITING

Countries

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Australia

Central Contacts

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Daniel Chambers

Role: CONTACT

(07) 3646 7498

Vidya Navaratnam

Role: CONTACT

(07) 3139 4000

Facility Contacts

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Daniel Chambers

Role: primary

736467498

Other Identifiers

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SHIELD

Identifier Type: -

Identifier Source: org_study_id

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