2015-05-012024-05-13https://scholars.lib.ntu.edu.tw/handle/123456789/649881摘要：由於基因體研究技術及生物生物資訊學的發展，利用全基因組關聯性分析在整個人類的基因體中找尋疾病相關的基因及其影響因子，成為醫學研究的重要方向。因此，生物檢體庫的建立已逐步成為生命科學從基礎研究、轉譯研究、臨床研究，到臨床藥物開發和應用的重要基石。本計畫的目的在建構一個技術及管理平台: 台灣婦女癌症生物資料庫。本計畫將有11家醫學中心参加，用以募集北、中及南部不同社經、族群和生活型態的婦癌病患。這個三期年計畫將募集約660位原位及侵襲性子宮頸癌、1665位子宮體癌、及1585位卵巢癌病患，收集生物檢體(組織、血液、及腹水)、追蹤病理診斷、治療過程、治療反應以及預後資料，並利用問卷訪視收集癌症相關危險因子，生活品質、睡眠及活動量表。本資料庫的組織架構包含合作醫院、中央資料庫、行政中心、及使用者委員會。各醫院將遵循共同的規範及標準程序進行檢體採集及保存，生物檢體將儲存於各醫院，疾病相關資料將藉由電腦傳輸集中保存於中央資料庫。行政中心將負責建立本網路運作的各類標準作業流程、人員訓練、提供問題的解決方法、與各合作醫院溝通及訊息交流。本計畫收集的生物檢體和資料開放研究者使用，使用者委員會審核檢體及資料的申請案，並監督檢體使用的正確及公平性。台灣婦女癌症生物資料庫，將提升婦女癌症偵測、診斷和治療的整體水準，可強化與國際醫療機構間的合作，為我國婦女癌症臨研究提供了重要的技術平臺，促進婦女癌症早期預防、診斷和尋找新的治療方法和策略提供突破契機。<br> Abstract: The epidemiological and clinical pattern of gynecologic cancers is unique, and this has triggered significant impacts on women’s health in Taiwan. However, the underlying cause of the phenomenon has not been well identified. Although, advance of genomic research has developed new understanding of biomolecular mechanisms of gynecologic cancers, the access to a wide collection of biospecimens coupled with epidemiological and clinical data for a valid genomic research is limited. To offer high-quality biosamples with comprehensive data of clinical phenotype, risk factors, clinical treatments, follow-up data of treatment effects and vital status. The research group has constructed a technology and management platform - the Taiwan Gynecologic Cancer Network to support clinical, molecular, epidemiological, and translational researches.The TGC Network will maintain 11 co-operating hospitals. To collect more representative patients of gynecologic cancers with various ethnics, environmental and socioeconomic background, and life styles, we will select hospital in northern, central and southern Taiwan to join the network. Overall, the network plans to collect carcinoma in situ and invasive cervical cancer, uterine cancer, and ovarian cancers, the expected case numbers are 660, 1665 and 11585cases; respectively.The biospecimens in TGC Network includes tissues, plasma, peripheral blood mononucleated cells, and ascites. All the biospecimens will be stockpiled in each participating hospital without centralization, and will be provided to the applicants by random selection. Clinical information and patient self-reported data in the network include diagnosis, disease status, stage, medical history, family history of cancers and chronic diseases, menstrual history, hormone use, physical activity, quality of life and other disease relevant factors. A globally unique identification number transformed from several unique identifiers of each participant by a highly protected system is used for the storage of biosamples and information. Web base information system is applied for data collection and storage, administration, and biosample management. Also, the website (https://100sb204.cims.tw/) work as an interface between the TGC Network and researchers intending to apply the tissues and/or associated information. Also, it is a platform for applicants, management center and user committee to communicate with each other, and complete the application procedure.The TGC Network will play an essential role to tie chains of drug discovery together to support NRPB programs and pharmaceutical industries. The representative biosamples and comprehensive disease relevant data are able to discover previous unseen patterns in both pre-clinical and clinical research. The integration of biosample and data helps elucidate the link between genotype and phenotype, and control the confounding factors to construct valid studies. Additionally, biosamples with high quantity of biosamples in biobank shortens the time to collect statistically meaningful sample size. For clinical trial, the comprehensive disease relevant data in the network help make an accurate trial strategy. Additionally, in the future the infrastructure and the connection of the network can work as a management platform to facilitate multicenter clinical trials.生物資料庫卵巢癌子宮頸癌子宮體癌子宮內膜癌基因體研究轉譯醫學生活品質癌症危險因子