Another trial site for Rhythm Biosciences' ColoSTAT trial

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Monash Health has become the second hospital to join the Rhythm Biosciences (ASX:RHY) prospective clinical trial of ColoSTAT - its blood test for the early detection of colorectal cancer.

The first patients have also been recruited by Monash Health, said Rhythm Biosciences in a statement.

Monash Health, which has more than 16,000 staff working at over 40 locations, is Victoria’s largest public health service providing care to a quarter of Melbourne’s population.

Dr Stephen Pianko, the head of clinical trials at Monash Health, has been appointed the site’s principal investigator. Dr Pianko, also a gastroenterologist, has significant experience in clinical trials and research.

“Monash Health services a significant patient population which will allow us to access a broad spectrum of people for recruitment” said Rhythm CEO Glenn Gilbert.

“Coupled with Dr Pianko’s well recognised experience in and commitment to colonoscopy and his effective track record of clinical trial execution, Monash Health’s joining of our trial provides an important boost to recruiting participants to the study by the end of the year,” said Mr Gilbert.

The trial involves a prospective, cross-sectional, multi-centre study to evaluate the diagnostic performance of the ColoSTAT In Vitro Diagnostic relative to colonoscopy (primary endpoint).

Secondary endpoints include assessing the ability of ColoSTAT to detect advanced adenomas and a comparison of the performance of ColoSTAT with the currently used Faecal Immune Test (FIT) - both relative to colonoscopy.

The company said recruitment for the trial, of around 1,000 patients, is expected to be completed end of the calendar year 2019.