The work and aims of SPECTA for better clinical trials

Share :
Published: 27 Nov 2014
Views: 4497
Dr Vassilis Golfinopoulos - European Organization for Research and Treatment of Cancer (EORTC), Brussels, Belgium

Dr Golfinopoulos talks to ecancertv at the 26th EORTC-NCI-AACR Symposium about the work and aims of the Screening Patients for Efficient Clinical Trial Access framework (SPECTA).

You’ve seen a lot of discussion in this conference about that personalised medicine has been on the lips of everybody for a few years now, to the point that it’s basically wearing off. But you saw a lot of discussion at this conference based on diagnostics because a big component of what we call personalised medicine is the realisation that we can no longer be certain about the diagnosis. It used to be very simple: you got a tumour, you moved on to treatment. Now it’s not very simple to characterise the tumour and although initially we thought it was simple, you get a mutation and that’s it, then you move on, there are a lot of technical, analytical, organisational, logistic problems around getting that profile right so you can be certain that your drug works or does not work, at least you are certain where you get a good answer from your clinical trial at the end.

So SPECTA is the result of the EORTC realising that there’s a lot of activity done out there and nobody is organising it very well. We organised a structure where patients are basically diagnosed as best as possible with multiple technologies and starting with next generation sequencing, that’s what we do and during the whole process having as good quality control as possible. So we tried to have an excellent quality control in all stages of tumour acquisition, of tumour transfer, of tumour control, of DNA extraction, of testing, of reporting results, which is exciting given what has… or at least I have heard in this conference with all stakeholders taking a small piece of that pipeline and working on it and somebody needs to structure the whole thing together. So that’s what we’re basically doing.

Is SPECTA a framework that other organisations can use?

It is a framework. The field is so big that there is no point in EORTC pretending that we can do it ourselves; we have no such ambition. What we try to do is structure the field, so some people go to the open source philosophy – let’s open it up and put it out there, which is an excellent philosophy and we actually use it for parts of our platform. But we think that a structuring effect is necessary from somebody because what happens with the boring parts that are very, very important but nobody really wants to work on?

So that’s basically it, it’s a platform where many stakeholders, including private stakeholders, including public stakeholders, academic, come and work together to solve this issue of giving access to clinical trials for patients that need good molecular characterisation of their tumour.

What’s next for SPECTA?

We’re coming out of a very tiring two years which has been exciting for us. The initial obstacle we had to surmount was the opening of the platform to all sides, because you realise it was a very strange protocol, it was applied as a protocol. It was a very strange protocol to all sides because we’re asking for tumour tissue, we’re asking for registration of the patients and we don’t promise much in return. So they had to donate tissue and patient data in the promise that maybe they’d get something like a clinical trial at some point. So that was a bit scary for us but we managed to do it.

In SPECTAcolor, which is the first platform that’s open and it’s for colorectal cancer, we are almost close to 500 patients now and increasing steadily. We have opened 19 sites from 9 countries and so far everything works OK. We collect the tissue, we do our quality control, quality is fine, the logistics, the electronic infrastructure of this works very well. We have done our first batches of NGS sequencing so we’re extremely happy with that. At least we can prove that the model works.

The next step is to plug projects into that, that’s the first point. From our discussions it looks like many different partners are interested in plugging projects. So the possibilities include clinical trials, companies that want to run their clinical trials in the traditional way but they want the wealth of information that comes from sequencing to do correlations after the trial for their tumours. We have companies that actually want to select the patients based on our platform and there’s a lot of initial diagnostics because there is one diagnostic component, apart from the basic pathology inspector, which is next generation sequencing but there are multiple technologies like blood based biomarkers, for which we heard a lot in this conference, that need benchmarking with the current technologies. SPECTA can be used very well into that.

So that’s one next step and the second next step which is actually very close on the horizon is the opening of the platforms for lung cancer, brain tumours and melanoma, which all three are starting or have started regulatory submissions so they should be open pretty soon.

Where can I find more information on SPECTA?

As always, the EORTC website is the best place to go to, so it’s SPECTA is on the first page and we hope it will remain on the first page, on the home page, of our organisation so that’s where to go.