Systemic SclerosisNCT06472362
Chest CT Biomarkers as Prognostic Predictors in SSc-ILD
An observational study of Systemic Sclerosis, run by Royal Brompton & Harefield NHS Foundation Trust at 7 sites in 4 countries.
Trial summary
The goal of this retrospective observational study is to investigate whether novel imaging biomarkers of airways, vessels, and overall extent of fibrosis at baseline predict ILD progression, vasculopathy development, and survival in SSc-ILD. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Systemic Sclerosis
- What is being tested?
- HRCT biomarkers
- How many people
- 1,000 participants
- Where
- 7 sitesin 4 countries
- Study dates
- 1 Nov 2024to 31 Mar 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Secondary/tertiary care patients with SSc
Who may be able to join
- diagnosed with SSc
- ≥18 years old
- HRCT between 01/01/1990 and 31/12/2019
Who cannot join
- Patients who do not have SSc
- <18 years old
- lack of availability of HRCT imaging data
Trial locations and contacts
7 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
7 sites in 4 countries
Italy3 sites
Marche Polytechnic University
Ancona
Sassari University
Sassari
Siena University Hospital
Siena
United Kingdom2 sites
Leeds Hospital/University of Leeds
Leeds
Royal Brompton Hospital
London
About this study
Official title: Deep-learning Derived Chest Computed Tomography (CT) Biomarkers as Prognostic Predictors in Systemic Sclerosis Associated Interstitial Lung Disease (SSc-ILD)
The goal of this retrospective observational study is to investigate whether novel imaging biomarkers of airways, vessels, and overall extent of fibrosis at baseline predict ILD progression, vasculopathy development, and survival in SSc-ILD.
Read the detailed description
Interstitial lung disease (ILD or lung fibrosis=stiffening of the lungs by scar tissue) develops in over half of patients with systemic sclerosis (SSc). Whilst ILD remains stable in some patients, at least a third have progressively increasing fibrosis. There is a pressing need for accurate indicators that identify a) patients at higher risk of progression, needing immediate treatment to prevent further irreversible ILD; and b) patients at lower risk, not needing treatment.
In this study the prognostic potential and accuracy of machine-learning derived biomarkers to evaluate abnormalities that are difficult to quantify visually will be investigated. Whether novel high resolution computed tomography (HRCT) imaging biomarkers of airways, vessels, and overall extent of fibrosis at baseline can predict ILD progression, vasculopathy development, and survival will be investigated in a cohort of approximately 1,000 SSc-ILD patients.
The algorithm scores will be evaluated against survival using Cox proportional hazards modelling, while mixed effects model analysis will be used to assess links with change in lung function: forced vital capacity (FVC), diffusing capacity for carbon monoxide (DLco), and carbon monoxide transfer coefficient (Kco). The airway algorithm measuring traction bronchiectasis (dilatation of the airways due to surrounding fibrosis) may predict worsening of FVC, reflective of ILD progression. The vessel algorithm may predict decline in KCO, a marker of pulmonary vascular involvement. Exploratory analyses evaluating change in HRCT fibrosis extent over time for patients with repeat HRCTs will also be performed, and whether composite outcomes of change in HRCT and lung function variables improve long term outcome prediction and pave the way to their use in clinical trials and routine clinical use. Patients with trivial changes on CT will also be included to assess for very early changes that could be predictive of future decline. These algorithms will be combined with the findings of our previous study, which suggest that a certain type of pattern on CT called UIP predicts shorter survival.
- Conditions
- Systemic Sclerosis
- Being tested
- HRCT biomarkers
- Medical subject headings
- Scleroderma, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRCT biomarkersDiagnostic test
HRCT imaging biomarkers of airways, vessels, and overall extent of fibrosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
Transplant-free survival
Measured: 15 years
Pulmonary hypertension
Development of pulmonary hypertension
Measured: 15 years
Decline in FVC
Change in lung function measure FVC
Measured: 15 years
Decline in DLCO
Change in lung function measure DLCO
Measured: 15 years
Decline in KCO
Change in lung function measure KCO
Measured: 15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2024
- Study start1 Nov 2024
- Primary completionDec 2025 (estimated)
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic SclerosisStudies 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
- Retrospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Brompton & Harefield NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Imperial College London, Royal Free and University College Medical School, The Leeds Teaching Hospitals NHS Trust, Hannover Medical School, University of Siena, Università Politecnica delle Marche, Azienda Ospedaliero Universitaria di Sassari, Bichat Hospital
- Responsible party
- Sponsor
- Investigators
- Elisabetta A Renzoni, Principal investigator, Royal Brompton and Harefield Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06472362
- Sponsor's protocol ID
- RBH2
- Status last verified
- Sep 2025
- First submitted
- 11 Jun 2024
- Last updated
- 11 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deep-learning Derived Chest Computed Tomography (CT) Biomarkers as Prognostic Predictors in Systemic Sclerosis Associated Interstitial Lung Disease (SSc-ILD)
- ClinicalTrials.gov ID
- NCT06472362
- Acronym / sponsor ID
- RBH2
- Conditions
- Systemic Sclerosis
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Royal Brompton & Harefield NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Imperial College London, Royal Free and University College Medical School, The Leeds Teaching Hospitals NHS Trust, Hannover Medical School, University of Siena, Università Politecnica delle Marche, Azienda Ospedaliero Universitaria di Sassari, Bichat Hospital
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 25 Jun 2024 (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.
The goal of this retrospective observational study is to investigate whether novel imaging biomarkers of airways, vessels, and overall extent of fibrosis at baseline predict ILD progression, vasculopathy development, and survival in SSc-ILD.
Detailed description
Interstitial lung disease (ILD or lung fibrosis=stiffening of the lungs by scar tissue) develops in over half of patients with systemic sclerosis (SSc). Whilst ILD remains stable in some patients, at least a third have progressively increasing fibrosis. There is a pressing need for accurate indicators that identify a) patients at higher risk of progression, needing immediate treatment to prevent further irreversible ILD; and b) patients at lower risk, not needing treatment.
In this study the prognostic potential and accuracy of machine-learning derived biomarkers to evaluate abnormalities that are difficult to quantify visually will be investigated. Whether novel high resolution computed tomography (HRCT) imaging biomarkers of airways, vessels, and overall extent of fibrosis at baseline can predict ILD progression, vasculopathy development, and survival will be investigated in a cohort of approximately 1,000 SSc-ILD patients.
The algorithm scores will be evaluated against survival using Cox proportional hazards modelling, while mixed effects model analysis will be used to assess links with change in lung function: forced vital capacity (FVC), diffusing capacity for carbon monoxide (DLco), and carbon monoxide transfer coefficient (Kco). The airway algorithm measuring traction bronchiectasis (dilatation of the airways due to surrounding fibrosis) may predict worsening of FVC, reflective of ILD progression. The vessel algorithm may predict decline in KCO, a marker of pulmonary vascular involvement. Exploratory analyses evaluating change in HRCT fibrosis extent over time for patients with repeat HRCTs will also be performed, and whether composite outcomes of change in HRCT and lung function variables improve long term outcome prediction and pave the way to their use in clinical trials and routine clinical use. Patients with trivial changes on CT will also be included to assess for very early changes that could be predictive of future decline. These algorithms will be combined with the findings of our previous study, which suggest that a certain type of pattern on CT called UIP predicts shorter survival.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Secondary/tertiary care patients with SSc
Key inclusion criteria (3 listed)
- diagnosed with SSc
- ≥18 years old
- HRCT between 01/01/1990 and 31/12/2019
Key exclusion criteria (3 listed)
- Patients who do not have SSc
- <18 years old
- lack of availability of HRCT imaging data
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 |
|---|---|---|
| HRCT biomarkersHRCT imaging biomarkers of airways, vessels, and overall extent of fibrosis | Diagnostic test | – |
Primary outcome
Survival
Time frame: 15 years
Transplant-free survival
Pulmonary hypertension
Time frame: 15 years
Development of pulmonary hypertension
Decline in FVC
Time frame: 15 years
Change in lung function measure FVC
Decline in DLCO
Time frame: 15 years
Change in lung function measure DLCO
Decline in KCO
Time frame: 15 years
Change in lung function measure KCO
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2025.
- Individual participant dataSharing planned: No
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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.
Elisabetta A Renzoni principal investigator
Royal Brompton and Harefield Hospitals
7 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Systemic Sclerosis, run by Royal Brompton & Harefield NHS Foundation Trust at 7 sites in 4 countries.
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 3 inclusion and 3 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: enrolling by invitation, as of the sponsor's last update on 11 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Italy, United Kingdom, France, Germany. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival (time frame: 15 years). The study lists 5 primary outcomes in all. 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 11 Sep 2025.