Sandusky George E, Teheny Katie Heinz, Esterman Mike, Hanson Jeff, Williams Stephen D
Lilly Research Labs and Indiana University Cancer Center, Indianapolis, IN 46285, USA.
Cell Tissue Bank. 2007;8(4):287-95. doi: 10.1007/s10561-007-9037-0. Epub 2007 Mar 27.
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.
分子研究在临床和基础研究领域的成功及其应用在很大程度上依赖于新鲜人体组织样本的采集、处理、储存和质量控制。这个组织库的建立是为了利用临床注释组织数据库（CATD）储存手术获取的新鲜人体组织，以便使用单向患者加密方案获取相关患者的临床数据和人口统计学信息，从而保护患者身份。在本研究中，我们确定高质量的组织样本对于基因组和蛋白质组分子研究都至关重要。本文还简要汇编了涉及患者伦理、患者知情同意、患者身份去识别、组织采集、处理和储存以及使用良好临床实践从组织库开展的基础分子研究的文献。文中简要讨论了当前处理人体组织适用的规则、法规和指南。在9年时间里，已有超过6610名癌症患者同意（同意者联系的患者中有97%同意），并从这些患者身上储存了16800份组织标本。组织库中收集的所有样本均由病理学家进行质量控制。大约有1550份组织样本被用于基础、临床和/或生物标志物癌症研究。从组织库中取出用于研究的每个组织等分试样都要经过第二次苏木精和伊红染色（H&E）评估，如果样本通过质量控制，就会被送去进行基因组和蛋白质组分子分析/研究。评估的样本中约75%具有高组织学质量并用于研究。自2003年以来，我们更改了患者知情同意书，以便组织库能够收集更多患者的临床随访信息。92%的患者（1865名患者）签署了新的知情同意书，并同意被再次联系以获取其疾病状态的随访信息。此外，85%的患者（1584名）同意被再次联系以提供用于生物标志物研究的生物体液样本。
