Reliable Research through Biobanking

By Wolfgang Thasler, Ludwig-Maximilians-Universität (LMU) Munich

The immense faith that patients have in their physicians greatly promotes the healing process, along with their hope to continue living. Sadly, in the case of advanced cancers, faith and hope do little.

Nevertheless, new knowledge about cancer gives rise to new hope. Studies have shown that with cancer, a damaged cell fails to disintegrate into its components and continues to replicate instead. Cell death in which the cell breaks into fragments is called apoptosis and this healthy process forms a vital balance with the complex healing process of regeneration. Signaling pathways strongly affect this balance. Researchers examining regeneration have been able to distinguish goodand bad factors within these signaling pathways. For example, the lack of a certain growth factor that improves liver regeneration seems to favor the development of liver cancer. Signaling pathways can malfunction in various ways and to different extents, and these malfunctions develop in various ways. This is why, apart from surgery to remove the cancerous part, there is no universal cure for cancer, and it is also why there are some cancers for which there is no cure.

At present, research results are largely based on statistical evaluation of vast amounts of data that have been acquired from examination of the regulatory processes within cells. The aim of such research is organ or cancer simulation through integrated modeling (see www.virtual-liver.de). This so-called systems biology approach allows us to determine how organs function and how cancer begins to develop. Moreover, it allows us to identify certain molecules called biomarkers that ultimately provide information about how treatable a cancer is.

Blood or tissue samples routinely taken from patients act as inexhaustible sources of data for this kind of modeling. These samples yield information on genetic material (DNA), regulatory molecules (RNA), proteins, etc. Another source of data is patients’ medical records. For instance, cancer patients at the Clinic for General, Visceral, Transplantation, Vascular and Thoracic Surgery at the University of Munich Medical Centre can opt to make their tissue and blood samples available for research along with their personal data. But this form of data retention for research purposes raises many issues: What methods are to be used for collecting, processing and storing the tissue samples? What ethical and legal standards have to be observed? What data are important to include? How can personal data be linked to the samples, and how can privacy be guaranteed? And how can access to these data be controlled and how are the related costs to be borne?

These issues, which address the processes needed for acquiring knowledge about human tissues from specific experiments, have great significance. For several years now, researchers at the Biobank under the administration of Human Tissue and Cell Research Foundation (HTCR) at the University of Munich Medical Centre have been systematically working on these issues as part of interdisciplinary research. The clinic has already carried out research that ensures the data meet certified quality management requirements (DIN EN ISO 9001: 2008). This requires the development and maintenance of standardized, fully documented procedures as well as following structured data acquisition and output practices.

In tissue research, experimenting with fresh tissue and/or living cells is clearly preferable to experimenting with other sample types — for example, cells preserved by shock-freezing with storage at -80°C or lower temperatures, which are nevertheless useful as “reference samples”. Thus, there is now a greater need for biobanks to ensure the availability of fresh samples for research. This will require improvements in preservation logistics (see, for example, EP1149900 ) and in the clinical infrastructure linked to patient care. However, “biobanking” is unfortunately still widely synonymous with the “archiving” of tissues or having access to diagnostic archives, where future use for research was not intended or is uncertain. From an ethical perspective, only close, independent and external governance can ensure that biobanking fully respects patient-physician relationship, necessary for successful treatment.

Given this background, the challenge that surgeons face is living up to the faith that patients have and will have in biobanking research. Considering the modest means available for biobanking at clinics — despite some recent public funding initiatives — biobanking will ultimately be sustainable and successful only through continuous participation by patients, as the tissue (for example, that from the removed tumor) is their property. Since 2004, at the Clinic for General, Visceral, Transplantation, Vascular and Thoracic Surgery at the University of Munich Medical Centre, patients wishing to make their tissue and data available for research may do so in the form of a donation via the Human Tissue and Cell Research foundation (see www.htcr.org).

The main aim in the future is to link existing research infrastructures to a joint biobank network. To this end, the m⁴ Biobank Alliance project was initiated in Munich in 2010 with support from the m⁴ leading-edge cluster funding (see www.m4.de). Based on a common standard of sample and data acquisition, as well as a shared policy concerning ethical and legal frameworks, this biobank network will provide a greater variety of research materials and greater information on cases of cancer subpopulations and rare diseases for cancer researchers.

Wolfgang Thasler
Ludwig-Maximilians-Universität (LMU) Munich
www.atomiumculture.eu