TILT
Research type
Research Study
Full title
A Trial of Intra-pleuraL OK-432 Therapy in mesothelioma (TILT): A feasibility study using the ‘trial within a cohort’ methodology \n
IRAS ID
215394
Contact name
Nick Maskell
Contact email
Sponsor organisation
North Bristol NHS Trust Research & Innovation
Eudract number
2016-004727-23
Duration of Study in the UK
1 years, 3 months, 0 days
Research summary
\nMesothelioma is an aggressive cancer that affects the lung lining. It is incurable, and there is only one effective chemotherapy, which extends life by just three months. New treatments are desperately needed. \n\nOne potential treatment targets the immune system. A healthy immune system identifies and attacks cancer cells, but mesothelioma hides from protective immune cells, and therefore escapes attack. Our research will use a “dead” bacteria, called OK-432, to stimulate immune cells to attack the mesothelioma. This may help people live longer with mesothelioma. \n\nTILT is a feasibility study using the trial within a cohort design. The design allows us to embed the trial in an existing cohort study, called ASSESS-meso. Participants in ASSESS-meso have agreed for their information to be used to identify clinical trials they may be suitable for, and to be randomly selected to join those trials. We will identify 45 people who are suitable for TILT, and randomly select 25 of them to receive OK432. They will be asked to consent to receive a single dose of OK432, delivered via an indwelling pleural catheter. \n\nThe 20 participants who are not selected will continue follow-up in ASSESS-meso, receiving usual care. They will provide control data for TILT, having given prior consent for their information to be used in this way. They will not be told about OK432 as, in real life, patients are not told about treatments that they do not receive. This potentially reduces disappointment in the observational arm, as mesothelioma patients often join trials hoping to receive new treatments. \n\nAt the end of the trial we will assess the feasibility of the methodology, based on recruitment rates, uptake of OK432 and data completeness rates. We will also interview participants and their relatives to explore the acceptability of the trial design to them.\n
REC name
South West - Central Bristol Research Ethics Committee
REC reference
17/SW/0080
Date of REC Opinion
10 Apr 2017
REC opinion
Favourable Opinion