NCT05546944

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 16, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 15, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 21, 2022

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

September 21, 2022

Status Verified

March 1, 2022

Enrollment Period

1.8 years

First QC Date

September 15, 2022

Last Update Submit

September 15, 2022

Conditions

Keywords

SilicosisPneumoconiosislung diseases

Outcome Measures

Primary Outcomes (1)

  • 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.

    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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Prince Charles Hospital

Brisbane, Queensland, Australia

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Biomarkers (blood ACE and ferritin)

MeSH Terms

Conditions

SilicosisPneumoconiosisLung Diseases

Condition Hierarchy (Ancestors)

Lung Diseases, InterstitialRespiratory Tract DiseasesLung InjuryOccupational Diseases

Study Officials

  • Daniel Chambers

    The Prince Charles Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 15, 2022

First Posted

September 21, 2022

Study Start

August 16, 2022

Primary Completion

June 1, 2024

Study Completion

December 1, 2024

Last Updated

September 21, 2022

Record last verified: 2022-03

Locations