项目来源
台湾省政府科研基金(GRB)
项目主持人
王功亮
项目受资助机构
台湾省基督长老教会马偕纪念社会事业基金会马偕纪念医院妇产科
项目编号
MOST103-2325-B195-002
立项年度
2014
立项时间
未公开
项目级别
省级
研究期限
未知 / 未知
受资助金额
4000.00千元台币
学科
临床医学；生物技术(医)
学科代码
未公开
基金类别
技术发展/学术补助
关键词
未公开
参与者
张廷彰；朱堂元；周振阳；林浩；余慕贤；洪耀钦；陈祈安；何志明
参与机构
未公开
项目标书摘要：在台湾，妇科癌症包含子宫颈癌、子宫癌，以及卵巢/输卵管/腹膜癌每年严重威胁着 4600位女性的生命并有1300位妇女因妇科癌症死亡，新的诊断工具、治疗和药物将为癌症患者带来希望。为了加速对抗癌症的药物的发现和使用，我们需要一个包含转译医学、临床试验设计、资料管理及分析及临床专科医师等的专家，共同规划并执行临床试验。台湾妇癌临床试验合作联盟(TGOG)因此成立，提供一个整合的平台来进行全国跨院性的妇癌相关研究。过去两年，在生技医药国家型科技计划(NRPB)的支持下，我们设立并强化了内部组织各委员会，并确立临床研究的执行流程和资料登录(与TR6合作),使各试验的执行更容易并更有品质。最重要的是，我们每个月皆举行研究月会及每季皆举办讨论会，由全台湾21个医疗院所医师及研究员共同参与。过去共执行了超过22个计划主持人主导型临床试验、7个联盟发起的新治疗/新诊断工具的临床试验、以及8个药厂/生技公司发起的临床试验，并共有6篇论文发表於国际期刊。我们对於子宫颈神经内分泌细胞癌的研究，拥有全世界最多的病例数，根据研究结果改变了这高度侵犯性癌症的治疗原则；同时和韩国妇癌研究团体及亚洲妇癌研究团体合作研究以增进我们在亚太地区的国际能见度。另外，由我们联盟发起的子宫颈癌甲基化研究，是个由基础医学研究转译到临床应用并开发为商业化诊断套组的成功案例，未来将可应用在大规模的癌症和癌前病变筛检。我们联盟致力於联合全台湾的妇癌专家来执行NRPB、非NRPB及药厂发起的临床研究或试验，期待不久的将来，本试验联盟能成为亚太地区最好的妇癌研究团体之一，不仅仅是国际上有竞争力的临床试验平台，并可高品质且有效率执行台湾生技公司发起的临床试验，以期降低台湾妇癌病患并发症及死亡率。
Application Abstract: Gynecological cancers,including cervical cancer,uterine cancer and ovarian/fallopian tube/peritoneal cancer are devastating diseases that affect more than 4600 women each year in Taiwan.Although current medical technology prolongs cancer patient survival,approximately 1300 women still died from these diseases annually.New treatment,diagnostic kits and drugs offer hope for patients with theses devastating diseases.To accelerate availability of life-changing therapies for these patients in the war against cancer,we need a network of experts in translational medicine,clinical protocol designing,data managing and analysis and clinical specialists for patient recruitment in great quantity.Taiwan Clinical Trial Consortium for Gynecologic Oncology(TGOG)was initiated to offer a promising platform for clinical trials of gynecologic cancers in Taiwan.Over the past two years with the support of National Research Program for Biopharmaceuticals(NPRB),the infrastructure of our consortium consists of steering committee,disease committees,and collaborative clinical trial committee.Every proposal must be ascertained by statistician for protocol design and Clinical Study Information System(CSIS)is used in managing protocols as well as patient and research data to produce uniform case report for analysis.Most importantly,monthly meetings and seasonal educational programs were held with researchers and doctors from 21 medical institutes all over Taiwan to collaboratively carry out clinical trials.More than 22 investigator initiated clinical studies,7 consortium initiated clinical trials for treatment/diagnostic kits and 8 pharmaceutical company initiated clinical trials(5 international and 3 domestic companies)had been implemented and contributed to 6 academic papers published in world renowned journals.Particularly,our study in small cell neuroendocrine cervical cancer had the largest reported case numbers globally,which rendered results with clinical significance that could shift the paradigm for the treatment of this aggressive cancer.Collaborative studies with Korean Gynecologic Oncology Group(KGOG)and Asian Gynecologic Oncology Group(AGOG)as well as webpage propagation further enhanced our international visibility for gynecologic oncology clinical trials.Moreover,our prospective study on cervical cancer detection using methylation biomarkers represented a good model for our consortium.This clinical trial was initiated by one of our research investigators through the TGOG platform over 2-year duration.It not only depicts the flow from translational medicine to not only market introduction but also clinical practice.A domestic pharmaceutical company transformed this clinical result into a commercialized diagnostic kit,which will soon be available for the massive cancer screening market.Our project(TR8)had been dedicated to collaborating gynecologic oncologists from all parts of Taiwan to cooperatively conduct NRPB initiated,non-NRPB initiated or international pharmaceutical company initiated pre-clinical studies and clinical trials.In the near future,we believe that TGOG is among one of the best gynecologic cancer clinical trial groups in Asia-Pacific,which provides not only an internationally competitive clinical trial platform,but also a venue where domestic biotech companies can initiate clinical trials.
项目受资助省
台湾省
