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We run our blog to keep you up to date with what we are doing, our progress and our findings. If you have a subject you would like us to blog about please get in touch.

  • Does your family have the rogue bowel cancer gene?

    posted on Thursday, 5th June 2014

    Not tagged.

    LYNCH syndrome is deadly but new tests and treatment could help identify and beat it, says campaigner and bowel cancer survivor Lynn Faulds Wood.

    Read the full article on the EXPRESS website.

  • CaPP3: progress towards a launch in 2014

    posted on Monday, 10th February 2014

    Not tagged.

    CaPP3: progress towards a launch in 2014

    In 2009, we saw the first evidence that aspirin offered a delayed protection against cancer in Lynch syndrome.  We immediately started dusting off our long held plans for a further study to see if low dose aspirin would be as effective as the 2 tablets a day we had tested in CAPP2. All agreed we should develop CaPP3 but first we agreed we needed to get CAPP2 published.  That took longer than expected.  After initial rejection by the New England Journal of Medicine, we took our work to the Lancet where it eventually appeared online in October 2011 and in hard copy in December 2011. 

    You can view the paper online at the Lancet website.

    Meanwhile we had developed a detailed plan to test different doses of aspirin.  Statistical analysis indicated we would need to find 3000 people to compare the effects of 2 tablets (600mg), versus 1 tablet (300mg) versus a quarter tablet (100mg).  The increase in international bureaucracy around clinical trials meant we would need to set up each country separately so we designed a study based on the UK population and prepared to submit an application for funding in early 2011. 

    We approached Bayer, who had supported CAPP2 and received encouragement.  While they could not accept responsibility for directly funding a trial of an off patent drug, their long term involvement as the inventors of aspirin and their continued involvement in the international aspirin market prompted them to offer to supply the several million tablets in active and placebo form needed to carry out the study.

    An unexpected turn of events in Spring 2011 was the opportunity to bid for support to traders in the international bond market as a "humanitarian cause" which could benefit from their profits while allowing them to take advantage of more generous trading conditions.  We were promised 5 million euros but sadly, the turbulence in the bond markets throughout 2011 meant that this promise was not fulfilled and we withdrew from that option in late 2011.

    An application was written to the UK National Institute of Health Research in autumn 2011 under their "Efficacy and Mechanism Evaluation" or EME programme.  This was rejected.  Instead we designed an application to the Health Technology Assessment programme for their deadline in January.  This was accepted as being of relevance to the NHS and put forward to the committee in July.  However we were not allowed to progress to a full application.

    As a separate exercise, CaPP3 had been presented several times to the Prevention sub-committee of the National Cancer Research Institute who have been consistently supportive.  With their encouragement, an outline was submitted to the Cancer Research UK Clinical Trials Awards and Advisory Committee (CTAAC) in April 2012.  This was given strong support by the Strategy group who recommended we be invited to submit a full application. The committee accepted this advice but required us to cut the budget.

    In March 2013 Cancer Research UK CTAAC awarded the funds to run CaPP3 in the UK for 7 seven years.

    The study will rely on the genetic and cancer research nurse network funded by the National Institute of Health Research Clinical Research Network to recruit to CaPP3 at all UK Regional Genetics Centres

    The study team is currently negotiating   the aspirin packaging contract under the EU Clinical Trials Regulations. The applications to the  national Multicentre Research Ethics Committee (MREC)  and Medicines and Healthcare Products Regulatory Agency (MHRA)  will be submitted at the end of February 2014. NHS approval will then need to be obtained at all 26 NHS organisations involved with the study. The full application and trial protocol with supporting documents will be shared with colleagues in the CaPP consortium outside the UK so that they can explore the feasibility of local clinical funding to allow them to join the effort.  If they can secure their local funds we can share the aspirin with them and offer randomisation and analysis services through the secure CaPP3 website.  This will ensure we get our 3000 recruits in a timely fashion and keep us on course for a final answer by 2021! 

    John Burn  Chief Investigator  10 February 2014

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