REPLICA
Research type
Research Study
Full title
Can performing extra tests on non-diagnostic biopsy samples avoid the need for further invasive biopsies in people with suspected cancer of the lung lining?
IRAS ID
329574
Contact name
Nick A Maskell
Contact email
Sponsor organisation
Research & Development North Bristol NHS Trust
Duration of Study in the UK
1 years, 6 months, 0 days
Research summary
Pleural mesothelioma (PM) is a cancer that affects the lining of the lung, caused by asbestos exposure. Despite recent treatment advances, average life expectancy remains under a year from diagnosis. Prompt diagnosis is therefore vital.
Patients usually require a biopsy for diagnosis, to guide treatment and assist with compensation claims. However, some need multiple biopsies which increases the risk of biopsy-related complications, delays diagnosis and risks missing the period in which someone is sufficiently strong to receive treatment.
Performing additional tests on biopsies could help diagnose PM sooner. This would shorten the diagnostic period, allowing patients to start anti-cancer treatment sooner and improve their chances of survival. Reducing the number of biopsies would eliminate the risks associated with multiple procedures.
The additional tests, while not genetic tests, look for markers of genetic changes associated with PM. Genes are our bodies’ building blocks and determine how we function. Some protective genes prevent or disarm tumours, but can be absent in PM, allowing the tumour to grow unchecked. The markers in PM are BAP1, p16 and MTAP and can be tested on biopsy samples. If they have disappeared, we can diagnose mesothelioma.
We previously studied people with suspected PM and a non-diagnostic first biopsy, so required further biopsies. We want to test these samples for BAP1, p16 and MTAP to see whether this could have made the diagnosis sooner, removing the need for further biopsies. We will investigate how many biopsies could have been avoided, how much time would have been saved, and any resulting cost-savings.
BAP1, p16 and MTAP are not routinely used in clinical practice, despite being relatively inexpensive. We hope to show how useful these tests are and how much benefit they offer to patients and NHS services, so they can be used more widely in routine care.
REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
24/EM/0042
Date of REC Opinion
28 Feb 2024
REC opinion
Favourable Opinion