Quality control of human tissues-experience from the Indiana University Cancer Center-Lilly Research Labs human tissue bank

Abstract

The success of molecular research and its applications in both the clinical and basic research arenas is strongly dependent on the collection, handling, storage, and quality control of fresh human tissue samples. This tissue bank was set up to bank fresh surgically obtained human tissue using a Clinical Annotated Tissue Database (CATD) in order to capture the associated patient clinical data and demographics using a one way patient encryption scheme to protect patient identification. In this study, we determined that high quality of tissue samples is imperative for both genomic and proteomic molecular research. This paper also contains a brief compilation of the literature involved in the patient ethics, patient informed consent, patient de-identification, tissue collection, processing, and storage as well as basic molecular research generated from the tissue bank using good clinical practices. The current applicable rules, regulations, and guidelines for handling human tissues are briefly discussed. More than 6,610 cancer patients have been consented (97% of those that were contacted by the consenter) and 16,800 tissue specimens have been banked from these patients in 9 years. All samples collected in the bank were QC'd by a pathologist. Approximately 1,550 tissue samples have been requested for use in basic, clinical, and/or biomarker cancer research studies. Each tissue aliquot removed from the bank for a research study were evaluated by a second H&E, if the samples passed the QC, they were submitted for genomic and proteomic molecular analysis/study. Approximately 75% of samples evaluated were of high histologic quality and used for research studies. Since 2003, we changed the patient informed consent to allow the tissue bank to gather more patient clinical follow-up information. Ninety two percent of the patients (1,865 patients) signed the new informed consent form and agreed to be re-contacted for follow-up information on their disease state. In addition, eighty five percent of patients (1,584) agreed to be re-contacted to provide a biological fluid sample to be used for biomarker research.

Review Paper: Human Tissues for Discovery Biomarker Pharmaceutical Research: The Experience of the Indiana University Simon Cancer Center—Lilly Research Labs Tissue/Fluid BioBank

“…For example, patients who have given consent can be enrolled and follow-up information appended only as long as the unidirectional encryption process is maintained as part of the system. 26 A modern cryptography-engineered solution was designed to provide sufficient security to counter escalating computing power, mathematical advances, and genetic computing developments, as well as ensuring one-way encryption. Message digests can provide the nonreversible nature, but standard configurations of related algorithms provide inadequate security.…”

“…Such extreme security is appropriate to assure long-term patient confidentiality in the face of advancing technologies. 26 Designing other data-security features An informatics system for leveraging humantissue research can store tissue descriptors, experimental results, and clinical annotations about the patient, disease pathology, and therapeutic outcomes. The system can facilitate data mining to show correlations between pathology profiles, target profiles, and outcomes.…”

“…A scientist can change the security level of any experiment he or she owns at any time, and the resulting setting with be handled by the security algorithm controlling the display of experimental results. 26 Handling and storing tissue specimens…”

Quality control of cultured tissues requires tools for quantitative analyses of heterogeneous features developed in manufacturing process

“…The repletion of QA for safety as well as efficacy of cultured tissues is one of the most critical issues to popularize their usage for transplantation (Lipson et al 2001;Alotto et al 2002;Tatarenko 2006;Sandusky et al 2007). In the case of drug production in pharmaceutical industry, as shown in Fig.…”

Avaliação do impacto da implantação do controle de qualidade em um banco de amostras teciduais criopreservadas

“…Isso se deve ao fato dos tecidos, da saliva e do próp rio ambiente terem altas co ncentrações de e nzimas líticas (RNAse s), q ue o degradam rap idamente (M icke et al, 200 6;Sandusky et al, 2007 ;.…”