Human biobank in uro-oncological research

PURPOSE. Uro-oncological translational research requires clinical data and human
biological tissues collected within a biological tissue bank (BTB). We are hereby outlining
ethic-legal, methodological and technical issues of a BTB establishment process, focusing
particularly on prostate cancer and Italian setting.
MATERIALS AND METHODS. Review of literature data, and national and international regulations
and guidelines; direct field experience of urological BTB; counseling of the different professionals
involved.
RESULTS. Within a BTB establishment process, it is of utmost importance to protect the
donors’ privacy and rights through the programmatic adoption of the following procedures:
1) informed consent; 2) confidentiality protection thanks to anonymity of biological specimens
and use of an “honest broker” method; 3) identification of a single responsible researcher;
4) dedicated and protected location; 5) approval of the Ethical Committee.
There are two main organizational models of BTB: “systematic”, i.e. collecting specimens
from all patients and through the same methodology; “project-driven”, i.e. prospectively
selecting patients for a specific study and using the specific methods required by researchers.
In the preliminary step it is necessary to establish detailed protocols of sampling and crioconservation
techniques, and methods of validation and quality control. For prostate tissue
sampling, several techniques have been described such as specimens of alternate slices,
macro dissection, Tru-Cut.
CONCLUSIONS. Today BTBs are necessary in order to support molecular and translational research
in uro-oncology, and to overcome the limits of the research based only on clinicalpathological
data. Ethic-legal and methodological issues related to BTBs are still requiring
specific legislation and standardization of techniques.