University of Colorado Southwest Oncology Group

描述(由申请人提供)： 科罗拉多大学癌症中心(UCCC)是落基山地区唯一由NCI指定的综合癌症中心，该地区约有800万人口。在过去的四年里，NCI赞助的研究投资组合一直稳定在约4000万美元，不包括核心拨款。门诊就诊和现在临床活跃的教员正在增长，我们希望这将转化为临床试验患者收益的显著增加。UCCC是科罗拉多大学丹佛分校(UCD)内的一个“矩阵”中心，并已完成搬迁到菲茨西蒙斯陆军基地(Anschutz Medical Campus)的新校区。它的主要临床护理中心包括科罗拉多大学医院(UGH)、丹佛退伍军人管理医疗中心(DVAMC)、丹佛健康医疗中心(DHMC)和丹佛儿童医院(TCH)。我们还有越来越多的外展诊所由我们的教员直接配备，包括蒙特罗斯的蒙特罗斯医院、格伦伍德斯普林斯的谷景医院和爱德华兹的韦尔谷医疗中心。其他一些正在开发中，包括阿拉莫萨。我们有附属公司(CGOP)，包括科罗拉多州斯普林斯的纪念医院和柯林斯堡的波德雷山谷医疗中心。我们由U10和UGOP资助的西南肿瘤学小组(SWOG)成员通过向科罗拉多州公民提供广泛的创新II和III期治疗和化学预防试验，实现了我们癌症中心的许多目标。这笔赠款为在主要机构、外联诊所和附属机构进行临床试验所需的监测和监督提供了部分支持。反过来，我们的教员也提供了强有力的行政和科学领导，特别是在GU和肺部委员会以及外科、病理和放射治疗模式方面，通过担任SWOG委员会的现任或主席，担任包括PCPT和SELECT在内的11/11期SWOG小组试验的PI，进行试点，为后续的SWOG试验提供基础，然后积累主题。我们预计，在下一个赠款周期，乳房委员会和GL委员会的活动将显著增加。临床试验代表了癌症治疗和预防的最先进水平，应该广泛提供给科罗拉多州的公民。 相关性：临床试验，特别是第三阶段研究，推动进展并建立新的护理标准(SOC)，然后必须加以改进。大多数III期肿瘤学试验证明实验臂优于以前的SOC，这并不是偶然的，但进展是渐进的。这笔赠款为我们的癌症中心和落基山地区的多个地点提供了必要的资源，以支持这些临床试验。获得临床试验对医疗保健的卓越至关重要。 首席调查员： Elias博士是UCCC的医学教授和临床科学副主任，也是科罗拉多大学乳腺癌临床项目的医学主任。在过去的6年里，他一直担任UCCC SWOG U10的PI。他完全有资格担任这一职务。 保护人类主体(简历)：可以接受 没有明显的担忧。 纳入妇女计划(简历)：可以接受 没有明显的担忧。 纳入少数族裔计划(简历)：可以接受 没有明显的担忧。 列入儿童计划(简历)：可以接受 登记的受试者一般为18岁或以上。 总体建议： 此应用程序的评级为33，建议使用六年的支持。

DESCRIPTION (provided by applicant): The University of Colorado Cancer Center (UCCC) is the only NCI-designated Comprehensive Cancer Center in the Rocky Mountain region - an area with a population of approximately eight million people. Over the past four years, the NCI sponsored research portfolio has remained stable at about $40 million, excluding the Core grant. Outpatient visits and now clinically active faculty are growing, which we hope will translate into a marked increase in patient accruals to clinical trials. UCCC is a "matrix" center within the University of Colorado Denver (UCD) and has completed its move to its new campus at the old Fitzsimons Army base (Anschutz Medical Campus). Its major clinical care centers include the University of Colorado Hospital (UGH), Denver Veterans Administration Medical Center (DVAMC), Denver Health Medical Center (DHMC), and The Children's Hospital Denver (TCH). We also have a growing number of outreach clinics staffed directly by our faculty including Montrose Hospital in Montrose, Valley View Hospital in Glenwood Springs, and Vail Valley Medical Center in Edwards. Others are in development including at Alamosa. We have affiliates (CGOPs) including Memorial Hospital in Colorado Springs and Poudre Valley Medical Center in Fort Collins. Our U10- and UGOP- funded membership in the Southwest Oncology Group (SWOG) fulfills many of the goals of our Cancer Center by providing broad access to innovative phase II and III treatment and chemoprevention trials to the citizens of Colorado. This grant provides partial support for the needed monitoring and oversight to run clinical trials at the main institutions and outreach clinics and affiliates. Our faculty, in turn, have provided strong administrative and scientific leadership, particularly in the GU and Lung Committees and the Surgery, Pathology and Radiation Therapy modalities as documented by serving or chairing SWOG committees, serving as PIs for phase ll/lll SWOG group trials including PCPT and SELECT, conducting pilots to provide the basis for subsequent SWOG trials, and then accruing subjects. We expect significantly increased activity in the Breast and Gl committees during the next grant cycle. Clinical trials represent the state-of-the-art in cancer treatment and prevention and should be broadly available and offered to the citizens of Colorado. RELEVANCE: Clinical trials, especially phase III studies, drive progress and establish new standards of care (SOC) that must then be improved on. It is no accident that the majority of phase III oncology trials prove that the experimental arm is superior to the previous SOC, but progress is incremental. This grant provides essential resources to support these clinical trials to our Cancer Center and to multiple sites around the Rocky Mountain region. Access to clinical trials is crucial for excellence in health care. PRINCIPAL INVESTIGATOR: Dr. Elias is a Professor of Medicine and Associate Director for Clinical Sciences for the UCCC as well as the Medical Director of the Breast Cancer Clinical Program at the University of Colorado. He has been the PI for the UCCC SWOG U10 for the past 6 years. He is fully qualified for his position. PROTECTION OF HUMAN SUBJECTS (Resume): ACCEPTABLE No concerns are evident. INCLUSION OF WOMEN PLAN (Resume): ACCEPTABLE No concerns are evident. INCLUSION OF MINORITIES PLAN (Resume): ACCEPTABLE No concerns are evident. INCLUSION OF CHILDREN PLAN (Resume): ACCEPTABLE Enrolled subjects are generally 18 years of age or older. OVERALL RECOMMENDATION: This application is rated 33 and is recommended for six years of support.