The SHIELD Study-silicosis

September 15, 2022 updated by: The University of Queensland

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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Anticipated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Queensland

Collaborators

The Alfred
Royal Prince Alfred Hospital, Sydney, Australia
The Prince Charles Hospital
Austin Hospital, Melbourne Australia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 16, 2022

Primary Completion (ANTICIPATED)

June 1, 2024

Study Completion (ANTICIPATED)

December 1, 2024

Study Registration Dates

First Submitted

September 15, 2022

First Submitted That Met QC Criteria

September 15, 2022

First Posted (ACTUAL)

September 21, 2022

Study Record Updates

Last Update Posted (ACTUAL)

September 21, 2022

Last Update Submitted That Met QC Criteria

September 15, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHIELD

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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