What next?
What next?
About this study
Interstitial lung disease (ILD) develops in over half of patients with systemic sclerosis (SSc). Whilst ILD remains stable in some people, at least a third have progressively increasing fibrosis. There is a pressing need for accurate indicators that identify people at higher risk of progression, needing immediate treatment to prevent further irreversible ILD; and also people at lower risk who do not need treatment.
This study will evaluate archived CT scans of 1,000 people with SSc-ILD; 500 from the Royal Brompton/Royal Free Hospitals and 500 from collaborating centres in Italy, Germany, and France. The researchers will assess survival and long-term lung function. They will then run analysis with computers.
One computer programme will work out the volume of the airways, which tends to be larger when there is fibrosis, and the researchers think that this may predict progression of ILD. Another computer programme will work out the volume of the blood vessels, which may predict the risk of developing pulmonary hypertension, which can be a major complication for people with SSc-ILD. A third computer programme will work out the overall amount of fibrosis, to assess whether this is a better predictor of survival and disease progression compared to traditional measures of lung function.
In the subgroup of people who have had repeat CTs over time, the researchers will also look to see if changes on CT scans can make prognostic estimates more precise. Together, these findings could provide the basis for doing a very large research study including many other centres across the world to ensure our results are applicable to all SSc-ILD patients.
The overall aim is to use novel imaging biomarkers to develop SSc-ILD specific computer programmes that predict what will happen for people with SSc-ILD.
There are many different types of research. These studies might ask participants to test different treatments, devices, or complete questionnaires. Some studies may not require any involvement from people affected by PF, but instead look at cells in a lab environment, animal models, or utilise computer modelling.
A study involving people can be:
- Interventional – participants are given an active treatment decided by researchers. This could be a change in medication or lifestyle (e.g. exercise, diet, complementary wellbeing therapy, or symptom management). These are commonly known as clinical trials.
- Observational – participants are assessed for specific changes over time, but researchers do not alter their standard treatment or care (e.g. questionnaires to understand the impact of symptom, or patient registries that track trends in how disease affects people or the services that are provided).
There are 3 main phases of clinical trials:
- Phase 1 is the earliest stage of research, where there is often a focus on understanding if the treatment is safe or if it causes any side effects.
- Phase 2 still focuses on safety and side effects, but also tries to find out more about what is the best dose.
- Phase 3 often compares the new treatment to existing treatments or lookalike medications.
As drugs or interventions move into the different phases, the number of people taking part will increase. Not all studies will make it to the later phases, especially if the intervention is not found to be safe or effective in phase 1 and 2.
The recruitment aim is the number of people that researcher want to take part in the research study.
What is involved?
No additional procedures are required. The study will only use data collected at previous hospital visits as part of routine clinical care.
Summary of involvement
Can I take part?
Your hospital records may be able to be used if you have a diagnosis of SSc, are aged 18 years and over and you received care at one of the participating hospitals between January 1990 and December 2019.
In research studies, there are lots of different reasons why you may or may not be able to take part. These are known as inclusion and exclusion criteria (see list below). Only the research team will be able to fully determine whether you are able to take part in the study. You can withdraw at any point without this effecting your usual care or treatment.
If you are not able to take part in this research study, there may be other opportunities for you to take part in different studies.
To find out more about other research opportunities visit our research finder main page.
You must be 18 years and over
A diagnosis of SSc
A previous HRCT scan must have been completed between 01/01/1990 and 31/12/2019
People who do not have a diagnosis of SSc
Those under 18 years old
Or a lack of availability of HRCT imaging scans
What difference could taking part make?
This precision medicine approach could lead to a step change in the management of care for people with SSc-ILD, reducing uncertainty over likely future outcomes, and enable early intervention with appropriate treatments and therapies, therefore potentially improving quality of life and prognosis.
Where does the study take place?
Study locations
How to take part
If you received care for SSc-ILD between January 1990 and December 2019 at the Royal Brompton and Harefield Hospital or Leeds Hospital, your hospital records may be used within this study. To find out more, please contact the lead researcher Dr Carmel JW Stock - c.stock@rbht.nhs.uk
Further information
This page is a summary which provides information about an opportunity to participate in research. More detailed information about the study can be found via the following the links and through contacting the research team.
If you have any questions about this research study, please speak to your medical team.
c.stock@rbht.nhs.ukThis study is supported by
APF does not endorse or recommend any specific study. All responsibility for the study remains with the sponsors and investigators.
Every effort is made to keep these details up to date. If you are aware of any inaccuracies, please email research@actionpf.org