What next?
What next?
About this study
Some people with pulmonary fibrosis receive a lung transplant. With any transplanted organs, including the lungs, there is a risk of rejection. If this occurs and is not treated, the transplanted organ can become damaged and will stop functioning. It is difficult to know if lung transplant rejection is happening, and people who receive a transplant need frequent tests to detect this.
The SENTINEL study aims to find out if a small patch of skin transplanted at the same time as the lung, from the same donor, can help to detect signs of transplant rejection earlier. This is called a sentinel skin flap. The skin is transplanted to the lower arm and acts as a way to visually check for potential rejection, showing a red rash. Currently, for lung transplants the only way to determine rejection is by doing a biopsy of the lung. It may also help to protect the lung transplant itself from rejection damage.
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?
Only patients already registered for lung transplant can be considered to take part in this study.
You will be randomly assigned to one of two groups.
- Group 1 will receive the lung transplant and the skin flap transplantation
- Group 2 will receive just the lung transplant
If you are in group 1, a skin flap transplantation measuring 10 x 3 cm will be placed on the underside of your forearm. Before you are discharged from hospital, you will be taught what skin changes to look out for. When you visit the hospital for routine follow-up appointments and tests, at 3, 6 and 12 months, you will have skin biopsies taken from the skin flap. In between those times, if you notice a rash or symptoms that there may be lung rejection, you will attend the hospital to undergo investigations.
If you are in group 2, and only receive the lung transplant, you will not have skin biopsies taken, but you will have tests, such as blood tests at your routine hospital visits at 3, 6, and 12 months.
Everyone taking part in the study will have the contact details for the transplant and research study team, if you have any questions or concerns.
Summary of involvement
Either receive a lung transplant and sentinel skin flap, or just a lung transplant
Medical tests at routine post-transplant appointments at 3, 6 and 12 months
Questionnaires
Can I take part?
You may be able to take part in the study if you are on the lung transplant list and a suitable lung becomes available.
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 clinical trial team will be able to fully determine whether you are able to take part in the study. You can withdraw at any point.
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 our more about other research opportunities visit our research finder main page.
Recipient of a lung transplant
Aged 18 years and over
Unable to give informed consent
Not registered for lung transplantation at one of the five study locations.
What difference could taking part make?
Taking part in this study may help researchers to understand if using a sentinel skin flap will help to detect or prevent rejection of lung transplantation. The results from the study will determine if the technique can be incorporated into routine clinical practice for future people receiving a lung transplant.
Where does the study take place?
Study locations
Cambridge
London
Birmingham
Newcastle
Manchester
How to take part
If you are on the waiting list for a lung transplant at one of the five study locations, you may be invited to take part in the study. You can also speak to your healthcare team to express your interest in taking part in research.
Further information
The summary on this page 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.
This 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