Dr Lauren Troy, Lead Investigator on the COLDICE Study and recipient of the inaugural PACT Grant-in-Aid for Investigator Led Pulmonary Fibrosis Clinical Research, sat down with the PACT team to talk about the study, including how it started and what the support of the PACT Grant-in-Aid will mean for this research.
Tell us a bit about yourself and why you chose PF as your research area:
I have worked in the Department of Respiratory Medicine at Royal Prince Alfred Hospital since 2009. I was fortunate to be there at the start of the RPAH Interstitial Lung Disease (ILD) Clinic, set up in 2011 by Dr Tamera Corte. Around that time, a lot of exciting changes were occurring globally in the field of pulmonary fibrosis and ILD in general. Once I finished my training, the decision to do further research in this area was very easy. I completed my PhD in pulmonary fibrosis related research at the end of 2016 and have continued working in the clinic ever since. Along the way, I decided to expand my training in respiratory diagnostic and interventional procedures, including learning how to perform cryobiopsies for ILD diagnosis. Over the past 3 years, my interests in ILD and respiratory diagnostics have come together in the COLDICE Study.
Describe your trial in a couple of sentences:
The COLDICE (Cryobiopsy versus Open Lung biopsy in the Diagnosis of Interstitial lung disease allianCE) Study is looking at how the cryobiopsy compares with the traditional surgical lung biopsy for ILD diagnosis. The cryobiopsy is a new technique for taking small samples of lung tissue through the airways, rather than through the chest wall, as is the current approach for surgical biopsies. The samples from cryobiopsy are much smaller than surgical biopsies, so it is not yet known if they are as accurate or reliable. Our study will help to answer this question, and hopefully inform clinicians when diagnosing their patients.
Tell us how this trial/ came about:
The COLDICE Study came about in 2015 when a few of us in the ILD Clinic heard about cryobiopsy being used with enthusiasm in some European hospitals. I remember having a chat over a team coffee about whether cryobiopsy results were accurate. We decided that we would create a study to answer the question. My colleague Dr Edmund Lau and I travelled to Tubingen in Germany to be trained in this new technique. We then collaborated with Dr Jonathan Williamson from Liverpool Hospital in Sydney, for further training. There was a lot of interest from many Australian hospitals. In the end, 9 sites took part in the study, which finished recruiting in April 2019. There was interest from New Zealand and American sites to join as well, but for logistical reasons it ultimately wasn’t possible. The study has been mentioned at international conferences and results are now awaited by the ILD community.
What do you hope this trial will achieve?
We hope to answer the question of whether cryobiopsies are a suitable alternative to surgical lung biopsies for ILD diagnosis. This is an important question, as the surgical lung biopsies carry some risk. Many ILD patients are too unwell to have a surgical biopsy so their diagnosis remains uncertain. This can impact on treatment decisions and outcomes. If there is a safer, reliable way to make a diagnosis, this would be preferable for many patients. Our preliminary results are very encouraging and support the role of cryobiopsy.
What has been the biggest challenge of the trial so far?
Where to start?! The challenges of the study have been more than offset by the tremendous support of many people. Aside from connecting with many clinicians and researchers in the fields of ILD and respiratory diagnostics, this study has shown me the generosity of people suffering with pulmonary fibrosis. I have heard over and over again how people wanted to participate to help others. By participating in the study, they felt strongly that they could benefit other sufferers of these diseases.
The people working on this trial are:
More than 50 people from around Australia and internationally have collaborated with us on this study. Aside from Edmund Lau, Tamera Corte and Jonathan Williamson, other key people have been Chris Grainge from John Hunter Hospital in Newcastle, Wendy Cooper and Annabelle Mahar from RPAH, Jeffrey Myers from Ann Arbour, Michigan, Ganesh Raghu from University of Washington Seattle and Michael Vallely from Macquarie University Hospital. Our study coordinators Tina Lin, Jessica Rhodes and Susanne Webster have been critical for the smooth running of the study and data entry.
What will the support of the PACT Grant-in-Aid mean for your clinical research/trial?
We are really grateful to receive the PACT Grant-in-Aid funding, which we plan to use for further research into specialised diagnostic testing in interstitial lung disease (ILD). We are hoping to extend the findings of the COLDICE study, incorporating new technologies such as digital pathology, micro-CT scanning and molecular sequencing. The field of ILD diagnosis is evolving at a rapid rate and our aim is to contribute to this in some way.
What do you see as the biggest evidence gaps in PF care? What are the clinical research priorities?
Large-scale international research is focusing on stopping the progression of pulmonary fibrosis, or at least slowing it down. Whilst these are very important things to target, there are many unmet needs of people living with these diseases. Quality of life and symptom control are relevant to all ILD sufferers and need to be the focus of current and future research.