ICI-M prognostic markers
Research type
Research Study
Full title
A retrospective review to identify clinical and subclinical prognostic markers of immune checkpoint inhibitor myocarditis
IRAS ID
367254
Contact name
Jessica Ball
Contact email
Sponsor organisation
University of Bristol
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
Immune checkpoint inhibitors (ICIs) are a type of immunotherapy commonly used to treat cancers such as melanoma and lung cancer. These drugs work by helping the immune system recognise and attack cancer cells more effectively. However, in some patients ICIs can cause the immune system to attack the heart, leading to a serious condition called myocarditis (heart inflammation). If not recognised and treated early, immunotherapy-related myocarditis can lead to severe problems in up to one in four patients. As these treatments have only been used routinely in the NHS for around a decade, there is limited information about why this complication occurs and how best to identify it early.
The primary aim of this study is to identify early clinical or heart imaging features that may predict the development or severity of myocarditis in adults receiving ICIs for treatment of their cancer. A secondary aim is to determine whether immunotherapy-related myocarditis differs from myocarditis caused by viral infection.
This study will involve adults aged 18 years or older who were treated with ICIs and later diagnosed with myocarditis. We will review historical medical records and heart scans from patients treated at NHS cancer centres across England and Wales over the past 10 years. No patients will be contacted, and participation will not affect current or future care.
By comparing patients with immunotherapy-related myocarditis to those with viral myocarditis, we hope to identify patterns that allow earlier diagnosis and treatment. This could help doctors monitor at-risk patients more closely, adjust treatment sooner, and ultimately make cancer immunotherapy safer. The research is supported through an academic training post held by the Chief Investigator and will run for approximately 36 months. We will share the results with doctors whose patients may benefit from these findings, patient advocacy groups and other researchers who work on similar things.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
26/NW/0110
Date of REC Opinion
20 Apr 2026
REC opinion
Favourable Opinion