2011-05-012024-05-14https://scholars.lib.ntu.edu.tw/handle/123456789/659405摘要：背景：胃癌仍然是全球癌症死亡原因中第二常見之癌症。消化性潰瘍也是造成民眾需要求診或住院的重要原因。幽門螺旋桿菌已被證實是導致胃癌及消化性潰瘍的重要致病原因，根除幽門螺旋桿菌可以減少消化性潰瘍的復發，甚至於可以降低胃癌的發生率。因此，在幽門桿菌相關之研究與研發，不但可以促進臨床診查與治療之進步，更可以增進台灣醫療及生物科技產業之發展。目標：因此我們想要1. 建置胃腸疾病患者及健康人之生物樣本及資料庫，以作為未來在臨床醫學、基礎醫學、以及醫療生物科技產業之合作平台。2. 建立台灣幽門桿菌相關疾病之臨床試驗聯盟，以進行台灣及國際多中心之臨床試驗。3. 開發幽門桿菌新的治療藥物以及抗藥性偵測之檢驗試劑。4. 開發胃癌及消化性潰瘍之早期診斷生物標誌及檢驗試劑。材料與方法：1. 機構：將有七個醫學中心及四個基礎醫學研究單位參與這個多中心之合作計畫。2. 服務：我們將在三年內收集600名胃癌，600名十二指腸潰瘍，600名胃潰瘍及1350位僅有胃炎病患的血液、胃組織檢體以及胃幽門桿菌菌株。此外，我們也將收集6000名接受全身健康檢查之民眾的血液檢體。這些民眾及患者都將接受胃鏡檢查，以確認是否罹患胃癌或消化性潰瘍等胃腸疾病。欲使用此生物資料庫之使用者，可提出申請書、計畫書、與倫理委員會核可書，由本單位之使用審查委員會審核通過後，即可購買點數並取得所需之檢體。使用審查委員會將根據計畫之科學價值以及臨床應用性予以評核。合作計畫：在這三年內，我們將進行三個多中心之臨床試驗，包括(1) 比較相繼式療法10天及14天與三合一療法14天在幽門桿菌第一線治療之療效。(2) 評估分子檢驗技術在偵測幽門桿菌抗藥性及第三線治療之角色。(3) 比較依據抗藥性選擇抗生素之裁量治療(tailored therapy)與經驗性三合一治療在幽門桿菌第一線之療效比較。研發計畫：我們將進行三項研發計畫，包括(1)開發胃癌及消化性潰瘍之早期診斷標誌與檢驗晶片；(2)開發幽門桿菌抗藥性與病人CYP2C19基因多樣性診斷晶片；(3)開發幽門桿菌治療之新式藥物。<br> Abstract: Background:Gastric cancer remains the second most common cause of cancer related death worldwide. Pepticulcer disease is also an important cause of hospitalization that requires a lot of medical costs.Helicobacter pylori (H. pylori) has been shown to be an important causal factor for non-cardiacgastric cancer, MALT type gastric lymphoma, and peptic ulcer disease. Accumulating evidenceshave suggested that eradication of H. pylori infection could reduce the recurrence rate of pepticulcer diseases and even reduce the occurrence of gastric cancer. Therefore, research anddevelopment of new diagnostic modalities and new therapeutic agents for H. pylori infection and itsassociated disease is crucial not only in the clinical practice but also in the development ofbiomedical industry.Objectives: Therefore, we aimed to1. Establish biospecimen banks for patients with gastroduodenal disease and for healthy controlsthat could provide as platform for basic research, clinical research, and biomedical industry2. Establish the Consortium of H. pylori associated disease in Taiwan that could conductimportant international multi-center trials in gastroduodenal diseases3. Develop new therapeutic drugs and diagnostic DNA kits for the detection of antibioticresistance in the treatment of H. pylori infection4. Develop diagnostic kits for early detection of gastric cancer and peptic ulcer diseaseMaterial and MethodsSettings: This multi-center collaborative research project includes 7 medical centers and 4 basicresearch units. Both clinicians and basic scientist are included.Service: We will include 600 patients with gastric cancer, 600 patients with duodenal ulcer, 600patients with gastric ulcer, 1350 patients with gastritis alone, and another 6000 healthy subjectsbetween June 1, 2011 and May 31, 2014. Blood samples (serum and plasma), peripheral bloodDNA, gastric tissue array containing gastric cancer and normal tissues, and H. pylori strains will becollected from these patients. H. pylori infection will be determined and upper endoscopy will beperformed to all patients and healthy subjects. Users (industry and academia units) can apply for theuse of these biospecimens with application forms, proposals, and approvals from institute reviewboard (IRB). The user committee will approve or disapprove the application based on the scientificmerits and clinical significance of the proposals.Collaborative Researches: Three clinical trials on the treatment of H. pylori infection will beconducted between May 1, 2011 and April 30, 2014. The first randomized control trial aimed toassess whether the sequential therapy for 10-day and 14-day would achieve better eradication ratesthan the standard triple therapy for 14-day. The second prospective pilot study aimed to assess theefficacy of susceptibility test -driven sequential therapy in the third line therapy for refractoryHelicobacter pylori infection. The third randomized trial aimed to compare the efficacy of tailoredtreatment versus the standard triple therapy in the first line treatment for H. pylori infection.Research and Development: We will focus on three topics. Firstly, we will try to develop diagnostickits for early detection of gastric cancer and peptic ulcer disease. Secondly, we will try to develop newDNA kit for the detection of antibiotic resistant H. pylori strains and host CYP2C19 polymorphism.Thridly, we will try to develop new therapeutic drugs in the treatment of H. pylori infection.胃癌幽門螺旋桿菌臨床試驗聯盟胃腸疾病Gastric cancerHelicobacter pyloriClinical trial consortiumGastroduodenal disease