Tissue Sample Collection, Processing, Storage, Archiving and Usage in the Leukemia Tissue Bank: an M. D. Anderson Experience

Introduction

Herein we present details of the standard procedures and operations of the Leukemia Sample Bank (LSB) as a guide to others desiring to establish their own bank. The availability of primary tissue samples to evaluate the molecular biology and pathogenesis of leukemia, as well as to develop and evaluate novel therapeutic strategies, has been instrumental to advances in the leukemia field. The Department of Leukemia at the University of Texas M. D. Anderson Cancer Center (MDACC) improves the treatment of patients with leukemias by providing basic, translational, and clinical scientists access to clinically annotated fresh and frozen primary tissue samples to test and validate their hypotheses. The LSB was created to collect, process, and maintain tissue specimens from patients with known or suspected hematologic malignancies, and also maintains a comprehensive, prospective, interactive database with detailed clinical and pathologic data and facilitates distribution of samples to various investigators.

Bank Design and Activity

An MDACC protocol was IRB approved in 2001 to facilitate primary leukemia tissue collection, storage, and distribution. The protocol serves as a "front door" consent to the Leukemia Department for approaching all new patients that come to the Leukemia Center. The protocol allows for use of tissue samples for current and future research projects related to researching hematological malignancies. Investigators utilize a separate IRB approved "back door" protocol, with a waiver of consent, to obtain samples for various projects. The LSB protocol thus serves as a single-sign research consent for patients, avoiding consent "fatigue" and ennui. A bank usage committee reviews request for samples and determines which to approve, including collaborations that are intra departmental, intra institution, inter academic institutional and with pharmaceutical institutions. A priority of usage is given to MDACC leukemia department investigators, other academic departments inside and outside MDACC, and finally to pharmaceutical institutions. Our policy is not to release the last vial of material for any particular patient. In the past year, these efforts have resulted in 93% of patients being approached, 82% providing consent, and only 11% declining. While most patients are motivated to consent to help advance research and improve treatments, hematology banks are unique in that they experience barriers to consent that solid tissue banks may not. Once blood and bone marrow samples are obtained, samples are processed per disease specific algorithms on the same day of collection to yield disease enriched material such as DNA, RNA, protein, serum or viable cells. Same day processing removes cryopreservation effects on labile analytes (mRNA, miRNA, protein) that could arise from a freeze thaw cycle. Material is distributed fresh to investigators or cryopreserved for later use. Samples are collected serially at the time of diagnosis, during therapy, in remission, or at relapse. The LSB provides annotated clinical data for any distributed samples. In support of the bank, a database records sample collection and archive details, and provides "chain of custody". A query tool was also developed allows for searching sample inventory by demographic, clinical, and sample characteristics, which also links to the Leukemia Clinical Data Repository (LCDR), to allow for searching of samples by leukemia specific characteristics such as diagnosis, prior treatments, and cytogenetic abnormalities.

Results

The LSB is one of the world's largest leukemia repositories and serves as a valuable local and national resource. The very high levels of patients consenting to participate make the holdings truly representative of all leukemias. The serial samples collected from patients allow for comparison between diagnosis and relapse states of disease. The ability to provide detailed annotation of clinical, laboratory, and outcome data further increases the value of research done with these samples. The LSB continues to collect valuable samples for use in research related to improving patient outcomes for patients with hematological malignancies.