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RELIVE flash

No.1 - May 2021

Welcome …

… to this first edition of the RELIVE flash, a news-flash for principal investigators, data managers, clinical research associates and everyone else who actively works for the RELIVE project. You are also invited to visit our website https://relive-international.net where all the documents necessary for the activation of the project are available. The website and project was presented and well received at the recent SIOPEL virtual meeting in Munich.

RELIVE PRESENTATION

The flash will appear about four times per year and is intended to keep you updated on all aspects of the RELIVE project. We would also love to hear from you, so please contact us for whatever topic and give us your news or concerns, we would be delighted to share it with everyone.

Marc Ansari

Status of activation

The study has been activated in Switzerland, and the first patient from Geneva University Hospital has been documented.

Ethics Committee approval has been obtained in Italy, Spain and Poland
In the Netherlands and in France, EC approval is not necessary.
In Germany, Japan, the UK and Belgium, EC submission is ongoing.
In the US and Canada, negotiations are under way to obtain the necessary approvals.

Relapse and resistance – the story so far

This is the title of the keynote lecture given by Alli O’Neill in the session on relapse / resistance held on March 11 during the virtual SIOPEL meeting organized by the new SIOPEL president Sophie Branchereau and the team of Beate Häberle and Irene Schmid in Munich.

The talk elegantly summarizes what we know and don’t know yet about the nature of and the treatment for such events.

KEYNOTE SPEECH

Progression? Refractory disease? Relapse?

Only patients who have suffered one of the events above can be included in the project. When you enter data, you have to specify the nature of the event. But how are they delineated?

Progression: The patient was never in remission and shows progressive rise in AFP (a documented rise in three successive AFP levels) or unequivocal tumor growth on imaging exams.

Refractory disease: The patient was never in remission and the tumor does not respond to treatment any more.

Relapse: The patient was in complete remission and now shows a progressive rise in AFP (a documented rise in AFP levels) or new findings on imaging examinations consistent with relapsed disease

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