5 Years Experience in Collecting Tumor Specimen at Patient's Tumor Bank of Hope (PATH) – A Decentralized, Independent Biobank in Germany Controlled by Patients.

Abstract

Abstract Purpose: PATH was established by a German breast cancer advocacy group in 2002. While there are other tumor banks around the world, the immediate benefit for the donating patient is not always clear. With PATH, we set out to prove that patients, physicians and researchers can join forces to operate a tumor bank at the highest ethical standards while collecting tumor specimen at highest and standardized quality. In addition, PATH has developed data acquisition and management methods for disease and therapy process and follow-up.Design: PATH Foundation is a non-profit organization.Seven certified German „breast centers“ are currently our partners. PATH is presented to patients in pre-OP discussion in these centers and they are given the opportunity to take part, by agreeing to an informed consent. The informational documents and consent form we give to patients were developed in collaboration with Prof. Taupitz of Germany's National Board of Ethics. The whole PATH procedure causes no additional cost for the patient.PATH tissuebank contains tumor-, normal tissue- and blood serum-specimen in fresh frozen quality stored in -152°C freezers or liquid nitrogen tanks. The first aliquot of each specimen is stored exclusively for the patient, the rest of the material is donated to PATH for research purposes. All cooperation partners (OB/Gyns and pathologists) commit to working strictly according to PATH's SOPs. There are 4 SOPs (extraction of blood serum und tissue aliquots, labeling of the specimen and quality-check with RIN assay).Cooperation partners' compliance and the implementation of the SOPs is monitored in biannual visits and meetings.All important data regarding tumor biology and therapy as well as sample processing are collected in PATH's own centrally managed MySQL database. The process was approved by the Bavarian Commission of Data Protection.Furthermore, PATH collects necessary follow-up data directly from the patient as well as from local tumor registries.Results: We began the collection of specimen in 2004.Data acquisition and implementation of the data base started in 2005. Follow-up began in late 2008. As of 04/2009, we have 3255 sufficiently documented patient data sets correlating with patients taking part in the PATH procedure (median age is 56). The available PATH collection contains 2732 tumor research specimen from 1251 patients (according to the last analysis of a collective of 2020 patients in 12/2008). Other quantities of collected specimen incl. patients' aliquot (ps') tumor = 1578; ps' normal tissue = 1591; ps' serum = 1876; resarch aliquots (ra) normal tissue = 2667; ra serum = 6068. This means that in 78,1% it was possible to collect a patient's tumor aliquot and in 61,9% at least one research specimen, varying with tumor stage.Conclusion: Over the last 5 years, PATH has gained broad experience in tumorbanking that is allowing it to operate a biobank at the highest ethical and qualitative standards. With its follow-up efforts, PATH will be able to provide a great variety of research specimen with at least a mean follow-up time of 5 years in 2011! Citation Information: Cancer Res 2009;69(24 Suppl):Abstract nr 3074.