Early stage biomarkers in ovarian cancer
Professor Angelo Paradiso – National Cancer Research Institute, Bari, Italy
The problems that we are discussing today are about a lot of potentially interesting biomarkers. Most of them are in the exploratory phases; this means that they are a little far from clinical practice or from a potential clinical application. There are very delicate steps that have to be overcome to move from exploratory to clinical research practice. The problem on which I focused my talk was what are those steps, which are the steps that we have to solve before moving to clinical prospective application? Pay attention – if I speak about clinical potential application, I mean application in prospective clinical trials; this means still in the experimental phase. But the delicate step is to move from the lab, from lab research, to clinical practice.
Before moving from lab to clinical practice and, if you like, from lab to bed, we have to guarantee that our biomarkers have to be determined according to some quality criteria. Most parts of the studies concerning biomarkers in recent times, last time, were completely limited in terms of applicability because the quality of the assay and the quality of the samples they utilised were not optimal. So if we want to move our biomarker to the clinics we have to guarantee that first of all the samples, the procedures that we adopt for collecting of samples and for laboratory practice are standardised, completely standardised from this point of view. The pre-analytical phase we mention as a pre-analytical all the phases coming before the laboratory assay; this means from the taking from the patient until the laboratory assay. This is a very delicate step, we have to check for all the timing and all the procedures to collect the samples and to move the samples to the lab, to be frozen and to move to the labs. So we need for that a standard operating procedure, what we call a standard operating procedure, that has to be determined and has to be proposed to clinicians before clinical application. This is the first. From the laboratory point of view our assay has to be granted to be reproducible and robust in terms of inter-assay and inter-laboratory reproducibility.
What does it mean? This means that we have to guarantee that if we determine our biomarker several times in the same lab the results will be similar and one more time, even more interesting, if one lab, if we determine our biomarker in one lab the results should be similar to what we obtain in another lab. Those are the aspects in which most parts of the last research failed in terms of guaranteeing that those steps were completely determined before moving to clinical practice.
My talk was concluded just suggesting what are the quality control programmes that are on-going in Europe concerning DNA determination, immunohistochemistry, sequencing analysis, PCR and RTPCR analysis, just suggesting to the floor to take part in that collaborative effort in terms of improving the quality of our labs in biomarker determination.
