The TRUFFLE2 Trial now has 28 sites open for recruitment. There are live sites across Europe including from the UK, Austria, Czech Republic, Italy, Germany, Norway, Switzerland, and Sweden. There are over 150 pre-eligible participants recruited to the trial, and over 20 patients have now been randomised. As always, live updates will be shared on our Twitter page!
With the COVID-19 situation affecting both travel and the logistical aspects of physical meetings, unfortunately we have had to defer the planned TRUFFLE meeting in Klagenfurt once again. The Klagenfurt meeting is now planned to be "in person" on 16-17 April 2021 hosted by Philipp Klaritsch and Kurt Hecher. When this event runs it will include a Fetal Growth Restriction course open to attendees outside of those working on TRUFFLE, as well as the TRUFFLE study meeting. The Fetal Growth Restriction course will be held on Friday 16th April, and the TRUFFLE meeting will be held on Saturday 17th April. Subject to travel restrictions we will be aiming to run a hybrid event, with both in-person and virtual options.
In January 2021 the TRUFFLE group hosted a short course on Fetal Growth Restriction, sponsored by GE Healthcare. International experts came together to give an intensive course on FGR diagnosis, management and outcome. The course was aimed at all involved in high risk perinatal care; fetal medicine specialists, obstetricians, neonatologists, radiologists, sonographers and midwives. The event, which was chaired by Professors Christoph Lees (UK) and Philipp Klaritsch (Austria), was attended by over 1000 participants from all over the world. Speakers included Kurt Hecher (Hamburg), Amar Bhide (London), Silvia Lobmaier (Munich), Katia Bilardo (Netherlands), Tamara Stampalija (Trieste), Raf Napolitano (London), Enrico Ferrazzi (Milan), Neil Marlow (London), and Herbert Valensise (Rome).
In October 2020 the TRUFFLE2 Investigators meeting took place as a webinar. Speakers included PI Philipp Klaritsch, Clinical Research Fellow Bonnie Mylrea-Foley, and PI Raf Napolitano. It was a chance to update all of the TRUFFLE centres on live site updates and recruitment, as well as hear about the process of Doppler Quality Control within TRUFFLE2, and an update on the Biomarkers Study.
The TRUFFLE 2 Trial went live on the 1st October with lead site Queen Charlotte's and Chelsea Hospital open for recruitment. University Hospital Jena and Tor Vergata University Policlinico Casilino Rome, have also opened for recruitment, with many more due to open over the coming weeks. The first pre-eligible participant has already been recruited. Live updates will be shared on twitter!
In June 2020 the TRUFFLE team hosted another Investigators meeting as a webinar. This included an update on the progress of the study, especially in view of COVID-19, and of changes to the planned Klagenfurt meeting. There was also a live demonstration of entering a patient into the CASTOR database, and the floor was then open for attendees to ask questions and have discussions. We are now planning a TRUFFLE meeting in Klagenfurt on the 24th of October 2020 (with an FGR Course on the 23rd October, which is open to those working outside of the TRUFFLE study). The TRUFFLE team try to meet in person roughly every 6 months in various locations, this has been postponed due to Covid-19, but we are hoping to be able to go ahead with this new date.
The TRUFFLE team try to meet roughly every 6 months in various locations, in order to discuss the international TRUFFLE2 trial. The next TRUFFLE meeting was scheduled for 17-18 April 2020 and was to be held in Klagenfurt, Austria. In view of the COVID-19 situation, and given advice from various Governments and travel restrictions by Universities and Hospitals, unfortunately we had no choice but to postpone this meeting until late 2020. Instead of the Klagenfurt TRUFFLE meeting that was planned for this time, this April the TRUFFLE team held an Investigators Webinar, so that all Investigators could safely join from accross Europe. Thank you so much to all of our TRUFFLE sites that were able to join, and for those centres that couldn’t join us but instead sent their updates. Another webinar will be scheduled for later in the year when we will have revised Klagenfurt meeting dates and more detail in relation to starting recruitment and quality control.
The TRUFFLE 2 study officially started in December 2019 and is in its final set-up period. Patient recruitment will run for two years starting in June 2020, followed by a further 2 years of neonatal follow-up. The study will aim to randomise almost 1600 women with late onset growth restriction to either immediate delivery (once cerebral redistribution is identified) or delayed delivery (based on cCTG changes).
A total of 53 centres will be taking part from the UK, Italy, Germany, Austria, Belgium, Sweden, Norway, Spain, Czech Republic, Switzerland, Russia and Estonia.
TRUFFLE 2 has taken over 5 years to plan, including multiple international meetings where collaborators have reached consensus on methodology. There will be a TRUFFLE collaborators “kick-off” meeting in April in Klagenfurt, and these meetings will continue at regular intervals throughout to study to ensure cohesion and communication between centres.
From December 2019 the study in the UK is being funded for 5 years by a £2.5m grant from the NIHR, which includes funds for 2.5 research midwives to co-ordinate UK centres. In addition, Imperial Health Charities have awarded a grant for a Clinical Research Fellow to co-ordinate study set up. A number of other funding applications are being submitted, both national applications for other countries and project grants for parallel studies planned such as maternal cardiovascular health and biomarkers.
Bronacha Mylrea-Foley, the clinical research fellow for TRUFFLE 2, along with Olive Adams, the TRUFFLE 2 research midwife, started visiting study centres in September. These visits continue with Jenny Goodier, another research midwife who has joined the TRUFFLE team. Their visits serve to disseminate the study plan to the research teams within each unit and ensure all sites are ready for the project start date. They have further visits lined up and aim to visit all European and UK study centres before recruitment begins.
There are several upcoming events on O&G and imaging in the next few months. Find out more information in the respective links.
Some photos from the recent TRUFFLE study meeting in Leuven, Belgium. Thanks to Dr Jute Richter and Professor Roland DeVlieger for hosting, and to all who attended for an excellent meeting.
The 2018 TRUFFLE study meeting took place in Turin, hosted by T. Todros and E. Bertino. Topics discussed include:
A selection of photos from the TRUFFLE study Berlin meeting in 2017.
Check out photos of the venue in Berlin for the TRUFFLE meeting 2nd December at Dr Bine Arabin' Foundation, visited by Christoph Lees today.
Dr Raf Napolitano was awarded by University College London Hospital's NHS Foundation Trust a research grant of £25,000 for one year to fund 50% of a Clinical Research Fellowship salary for the implementation of the TRUFFLE 2 Study at University College London Hospital.
We have published this new website to give information on the TRUFFLE study, our goals, and news about the ongoing feasibility study!