De-identification procedure and sample quality of the post-clinical test samples at the bio-repository of the National Cancer Center Hospital (NCCH) in Tokyo.

We established our bio-repository in October 2002. One of the unique aspects of our bio-repository is that it is based on post-clinical test samples. Although the post-clinical test sample-based storage is beneficial because ample clinical information is available for each sample and samples are to be refreshed regularly, many bio-bankers are hesitant to store them because of the possible problems of de-identification procedures and sample quality. Currently, we have two different types of sample, not de-identified status and de-identified status. Most of the samples for storage are not de-identified status. A portion of the samples are transferred to new tubes before and after being frozen, without clinical patient identifications and the status is de-identified. This tube transfer is the only de-identification procedure in our bio-repository so far. After a procedure of de-identification, these samples are stored. The de-identified samples are collected under various project-based schemes. The quality standards of our samples are established by two factors: pre-analytical quality control efforts, and record keeping of sample history by sample tracking system. All the samples have been phlebotomized under strict control of pre-analytical requirements. By record keeping of sample history with the sample tracking system, we can tell the exact temperature and elapsed time in various situations since the phlebotomy procedure or on arrival at the clinical laboratory. In this article, we will disclose how we have dealt with the de-identification procedure and sample quality.

Bio-repository of post-clinical test samples at the national cancer center hospital (NCCH) in Tokyo.

We established the Bio-repository at the National Cancer Center Hospital in October 2002. The main purpose of this article is to show the importance and usefulness of a bio-repository of post-clinical test samples not only for translational cancer research but also for routine clinical oncology by introducing the experience of setting up such a facility. Our basic concept of a post-clinical test sample is not as left-over waste, but rather as frozen evidence of a patient's pathological condition at a particular point. We can decode, if not all, most of the laboratory data from a post-clinical test sample. As a result, the bio-repository is able to provide not only the samples, but potentially all related laboratory data upon request. The areas of sample coverage are the following: sera after routine blood tests; sera after cross-match tests for transfusion; serum or plasma submitted at a patient's clinically important time period by the physician; and samples collected by the individual investigator. The formats of stored samples are plasma or serum, dried blood spot (DBS) and buffy coat. So far, 150 218 plasmas or sera, 35 253 DBS and 536 buffy coats have been registered for our bio-repository system. We arranged to provide samples to various concerned parties under strict legal and ethical agreements. Although the number of the utilized samples was initially limited, the inquiries for sample utilization are now increasing steadily from both research and clinical sources. Further efforts to increase the benefits of the repository are intended.