Developmental Core- Pilot Projects, Full Projects, Biostat Core and Outreach Prog

发展核心 - 试点项目、完整项目、Biostat 核心和外展计划

• 批准号: 7896560
• 负责人: RAYMOND N. DUBOIS
• 金额: $ 82.68万
• 依托单位: UNIVERSITY OF TX MD ANDERSON CAN CTR
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/7896560
• 关键词: 21 year old; Accounting; Address; Adult; Advertising; Affinity; Alcohol consumption; Area; Award; Basic Science; Behavior; Behavioral Sciences; Binding; Bioinformatics; Biological Assay; Biological Markers; Biometry; Biostatistics Core; Blood specimen; Body mass index; Body of uterus; Breast; Bromides; CD44 gene; Cancer Center; Cancer Control; Cancer Etiology; Carbohydrates; Case-Control Studies; Cause of Death; Cell Line; Cervical Cancer Screening; Cessation of life; Clinic; Clinical; Clinical Research; Clinical Trials; Collaborations; Collection; Colorectal Cancer; Combined Modality Therapy; Commit; Communication; Communities; Community Health; Complex; Comprehensive Cancer Center; Confidence Intervals; Consultations; Contraceptive methods; Contrast Media; Coupled; Cyclodextrins; Data; Data Analyses; Data Files; Databases; Development; Development Plans; Diabetes Mellitus; Diagnosis; Discipline of obstetrics; Doctor of Philosophy; Dose; Drug Formulations; Education and Outreach; Educational workshop; Electronic Mail; Endometrial Carcinoma; Ensure; Enzymes; Epidemiologist; Excipients; Faculty; Family history of; Family member; Feedback; Foundations; Funding; Future; Genetic Polymorphism; Glucosamine; Goals; Growth; Gynecologic; Gynecologic Oncology; Gynecology; Habits; Health; Health Care Costs; Health Personnel; Health behavior; Healthcare; Hispanics; Histologic; Hormone replacement therapy; Hospitals; Human; Human Papillomavirus; Human Resources; Immunoassay; In Vitro; Individual; Infertility; Institution; Insulin; Insulin Resistance; Insulin-Like Growth Factor Binding Protein 3; Insulin-Like Growth Factor I; Insulin-Like Growth Factor II; Interview; Iron; Laboratories; Lead; Length; Life; Linear Models; Link; Logistic Regressions; Logistics; Magnetic Resonance Imaging; Malignant Epithelial Cell; Malignant Neoplasms; Malignant neoplasm of cervix uteri; Marketing; Measurement; Measures; Mediating; Medical; Medical Students; Medicine; Mentors; Methodology; Modeling; Modification; Needs Assessment; Neoplasms; Newly Diagnosed; Newsletter; Nonsense-Mediated Decay; Odds Ratio; Outcome; Ovarian Carcinoma; Participant; Pathway interactions; Patients; Phosphorylation; Phosphorylation Site; Physical activity; Physicians; Pilot Projects; Population Sciences; Population Study; Prevention; Process; Public Health; Published Comment; Puerto Rican; Puerto Rico; Quality Control; RNA; RNA Splicing; Recording of previous events; Reporting; Reproductive History; Research; Research Design; Research Infrastructure; Research Personnel; Research Project Grants; Research Proposals; Research Training; Resources; Retrieval; Risk; Risk Factors; Risk Reduction; Role; Rotation; Sample Size; Sampling; Science; Scientist; Screening for Ovarian Cancer; Screening procedure; Series; Serum; Site; Smoke; Smoker; Smoking; Societies; Solubility; Somatomedins; Staging; Statistical Methods; Students; Survival Analysis; System; Tissue Sample; Tobacco; Tobacco use; Toxic effect; Training; Training Programs; Translational Research; Treatment Protocols; Underrepresented Minority; United States; Universities; University of Texas M D Anderson Cancer Center; Update; Uterine Cancer; Vaccination; Variant; Water; Weight; Woman; Xenograft Model; Xenograft procedure; Yeasts; abstracting; adiponectin; anticancer research; aptamer; aqueous; base; cancer health disparity; cancer prevention; cancer risk; career; career development; cervical cancer prevention; community based participatory research; community organizations; cost effectiveness; data management; data modeling; design; dissemination research; drinking; experience; genetic epidemiology; health disparity; health organization; high risk drinking; improved; indexing; insulin sensitivity; interest; investigator training; malignant breast neoplasm; mortality; neoplasm registry; next generation; novel; outreach; outreach program; pre-clinical; programs; reduce tobacco use; reproductive; research clinical testing; research study; smoking cessation; smoking prevalence; stoichiometry; success; theories; tobacco control; treatment effect; virtual

[For the resubmission, research projects that received high (non-competitive) scores on the summary statement were eliminated as suggested by the PSC (Table 47).] Four research projects, which include career development plans (following References in each individual proposal [and in Appendix D]), are included in this application. Three projects are continuations from the previous U54 award. [These projects have been presented to the PSC Committee on an annual basis for feedback. All comments for revision have been incorporated into the projects.] In addition to the projects included on this application, funding is available for 2 pre-pilots during the 1st year and 1 pre-pilot during the 2nd year. During the 3rd year, funding is available for 1 pilot project. During the 4th year, funding is available for 3 full projects, 7 pilot projects or a combination of full, pilot and pre-pilot projects for up to 2 years. All projects will undergo a thorough IAC review process to be evaluated on their potential to expand into a larger project under the U54 mechanism and to compete for external funding (See Section 7). A description of each full and pilot project is included following this introduction. In addition to the research projects, this application includes a Cancer Training Program, a Cancer Outreach Program, and support cores as described in the RFA. The Outreach Program is the continuation of a 2-year Pilot Program that started late in the previous funding cycle.] 8.4 Solicitation of New Projects and Programs One of the main objectives of this Partnership is to facilitate the growth of independently-funded research at the MSI. To achieve this goal, aggressive advertising'and marketing strategies are needed to solicit the best proposals with an emphasis on building the foundation and infrastructure of the UPRCCC. A number of mechanisms will be used to solicit faculty from both institutions to begin collaborating including: 1) Partnership and UPR Websites; 2) Campus Presentations; 3) MSI Office of Sponsored Research; 4)"email; 5) Email Newsletters; and 6) Virtual Community. Title: Pilot Project A: Pilot Case-Comparison Study of Insulin Resistance, Adiponectin and Endometrial Cancer in Puerto Rico ABSTRACT Cancer of the uterine corpus is the most common gynecologic malignancy in the United States, with 40,100 new cases and 7,470 cancer-related deaths estimated for 2008. Similarly, in Puerto Rico endometrial cancer is the most common gynecologic malignancy, and the third leading cause of cancer in women behind breast and colorectal cancer. In the year 2003, there were 321 new cases of endometrial cancer reported to the Puerto Rico Cancer Registry, accounting for 6% of all cancers in women. Recent observations suggest that new pathways need to be considered, including evidence for a possible role of insulin and the insulin-like growth factor system. We will conduct a case-comparison hospital-based pilot study to assess the role of insulin resistance and adiponectin, a biomarker of insulin resistance, as risk factors for endometrial cancer among Puerto Rican women. One hundred women (21 years and older) with a newly diagnosed, histologically confirmed primary endometrial cancer will be selected at the Gynecologic Oncology clinic of the Department of Obstetrics and Gynecology at the University of Puerto Rico Medical Science Campus (UPR-MSC) and compared to 100 women selected among attendees to two Obstetrics and Gynecology clinics at the UPRMSC. Participants will undergo a face-to-face interview in which the following is collected: demographic information, smoking and drinking habits, weight history, personal and family medical history, reproductive and menstrual history, history of contraception and hormone replacement therapy, history of infertility, and levels of physical activity. In addition, women will undergo anthropometric measurements and collection of blood samples for measurements of insulin resistance. Insulin resistance (IR) will be measured using the quantitative insulin sensitivity check index (QUICKI). In addition, serum adiponectin levels, which correlate with insulin resistance, will be measured using a commercially available quantitative sandwich enzyme-linked immunoassay (ELISA). Univariate and multivariate unconditional logistic regression models will be used to assess the association of endometrial cancer with insulin resistance and serum adiponectin. The odds ratio (OR) and its 95% confidence intervals will be used to estimate the strength of the association between IR and other factors of interest and endometrial cancer. TITLE: Training the Next Generation of Hispanic Cancer Researchers ABSTRACT Early recruitment of underrepresented minorities to biomedical and health research training is essential to ensure that society's diversity is reflected in those professions. The objective of this proposal is to strengthen its partners' capabilities to contribute to significant increases in the participation of underrepresented minorities in nationally competitive cancer clinical and basic research. The University of Puerto Rico (UPR) and the University of Texas M. D. Anderson Cancer Center (MDACC) will continue to develop a comprehensive pipeline program from undergraduates to postgraduates that will increase the number of Hispanic students knowledgeable and committed to careers in cancer research and cancer medicine. The overall goal of this project is to encourage Hispanic science and medical students to pursue careers in cancer research and medicine and populate the faculty ranks at the UPR so as to strengthen cancer research at the University of Puerto Rico. The University of Puerto Rico (UPR) is conducting the training program with MDACC in several areas - biomedical and clinical research, didactics, enrichment experiences, M.D./PhD. training, postgraduate clinical training, training in cancer prevention and health disparities, and career development. The desired outcome will be achieved through a coordinated series of didactic and research experiences and enrichment activities that include on-campus cancer research at University of Puerto Rico Comprehensive Cancer Center (UPRCCC) during the academic year and summer research and year-round rotations to MDACC. The program draws upon the strengths of both institutions and brings benefits to both. TITLE: Puerto Rico Community Cancer Control Outreach Program ABSTRACT Cancer is the second leading cause of death among Hispanics in the US.(1) Despite the overall decline in cancer mortality over the last decade, Hispanics continue to experience disparities for certain cancers.<2) Breast and cervical cancer and tobacco-related cancers are among these.'113|4) Although smoking prevalence is lower in Puerto Rico (PR) compared to the US, tobacco exerts a tremendous public health burden, with 11.5% of all deaths and 10% of all health care costs in PR are attributable to smoking.(4> Among Puerto Rican women living in PR, breast cancer is the most commonly diagnosed neoplasm (35% of all cancers) and the leading cause of cancer deaths (15% of total).(9) Cervical cancer is the 4th most commonly diagnosed neoplasm in PR women, accounting for 4% of all newly diagnosed cancers, and 2.4% of all cancer-related deaths.(9) The purpose of the Puerto Rico Community Cancer Control Outreach Program (CCCOP) is to modify and sustain health behavior through the development of comprehensive, sustainable partnerships for cancer control outreach, education, research, and training in Puerto Rico (PR). Specifically, the purpose of the CCCOP is to decrease tobacco use, increase vaccination against Human Papilloma Virus (HPV), and increase breast and cervical cancer screening. Program components of the CCCOP will build upon collaborations, infrastructure, network development, and outreach successes achieved in the Outreach Pilot Project. The specific aims of the CCCOP are to: 1. Maintain, strengthen, and further develop a cancer control outreach network that will build upon existing relationships and develop new collaborations among the University of Puerto Rico Comprehensive Cancer Center (UPRCCC), The University of Texas M. D. Anderson Cancer Center (MDACC), and key Puerto Rican community and health organizations; 2. Conduct a community assessment of needs and resources for breast and cervical cancer (BCCS) prevention and screening, tobacco control, and the elimination of disparities related to these cancers and behaviors; 3. Develop health care provider and community organization capacity to implement and sustain culturally competent cancer control outreach and education programs to address disparities in breast and cervical cancers and tobacco control; 4. Provide active mentoring and career development opportunities to U54 researchers and community partners to build capacity in cancer control and community-based participatory research; and, 5. Evaluate the impact of the CCCOP on increasing breast and cervical cancer screening, increasing HPV vaccination, and reducing tobacco use in PR. The proposed project provides benefits to both UPRCCC and MDACC as each partner brings unique expertise to the partnership. The CCCOP also includes major career development components to prepare cancer disparities researcher at both UPRCCC and MDACC. TITLE: Biostatistics and Bioinformatics Core ABSTRACT Rigorous application .of statistical methods and theory ensures that research will be conducted efficiently and increases the likelihood that useful data will be collected and correctly interpreted. The purpose of the Biostatistics and Bioinformatics Core (BBC) is to provide professional expertise in Biostatistics and Bioinformatics for all research studies within the Partnership. The investigators will have a close communication with the BBC at different stages of the projects, such as: study design, sampling design, sample size, random assignment, determination of statistical power, data description, data modeling, data management, quality control, database creation, keeping track of the database, merging files, updating files, data editing and filing, and retrieval of missing data. In addition, to improve our communication with the investigators, the BBC is planning to organize different workshops related with the statistical needs for every research studies, particularly with regression modeling (linear, logistic, multilevel), survival analysis, clinical trials, sample size, and power determination. Also, the BBC personnel will be involved in the assessment of new statistical methodologies in cancer research, particularly in microarray data analysis (McLachlan, et al, 2003) and genetic epidemiology (Suarez et al, 2007).

[对于重新提交，在摘要中获得高（非竞争性）分数的研究项目 根据 PSC 的建议，声明已被删除（表 47）。] 四个研究项目，其中包括职业生涯 发展计划（以下是每个单独提案中的参考文献[和附录D]），包含在本文件中 应用。三个项目是之前 U54 奖项的延续。 [这些项目已 每年提交给 PSC 委员会征求反馈。所有修改意见都有 已纳入项目。] 除了本申请中包含的项目外，第一年还可为 2 个预试点项目提供资金 第二年进行 1 名预试点。第三年，可资助 1 个试点项目。 4日期间 年，资金可用于 3 个完整项目、7 个试点项目或完整项目、试点项目和预试点项目的组合 长达 2 年。所有项目都将经过彻底的 IAC 审查流程，以评估其潜力 在U54机制下扩展为更大的项目并竞争外部资金（见第7节）。 本介绍之后包含对每个完整项目和试点项目的描述。除了研究之外 项目，该应用程序包括癌症培训计划、癌症外展计划和支持核心 如 RFA 中所述。外展计划是启动较晚的两年试点计划的延续 在上一个资助周期中。] 8.4 新项目和计划的征集 该伙伴关系的主要目标之一是促进独立资助研究的发展 MSI。为了实现这一目标，需要积极的广告和营销策略来征求最好的人才 提案的重点是建设UPRCCC的基础和基础设施。一些 将使用机制来征求两个机构的教师开始合作，包括： 1) 伙伴关系 和普遍定期审议网站； 2）校园展示； 3) MSI 资助研究办公室； 4）“电子邮件；5）电子邮件 时事通讯； 6) 虚拟社区。 标题：试点项目 A：胰岛素抵抗、脂联素和胰岛素抵抗的试点案例比较研究 波多黎各的子宫内膜癌 抽象的 子宫体癌是美国最常见的妇科恶性肿瘤，有 40,100 例 2008 年估计有 7,470 例新病例和 7,470 例与癌症相关的死亡。同样，在波多黎各，子宫内膜癌 是最常见的妇科恶性肿瘤，也是女性癌症中仅次于乳腺癌的第三大原因 和结直肠癌。 2003年，共报告了321例子宫内膜癌新病例。 波多黎各癌症登记处，占女性所有癌症的 6%。最近的观察表明 需要考虑新的途径，包括胰岛素和类胰岛素可能发挥作用的证据 生长因子系统。我们将进行一项以医院为基础的案例比较试点研究，以评估 胰岛素抵抗和脂联素（胰岛素抵抗的生物标志物）是子宫内膜癌的危险因素 在波多黎各妇女中。一百名女性（21 岁及以上）新诊断出组织学 确诊原发性子宫内膜癌将在妇科肿瘤科门诊选择 波多黎各大学医学科学校区 (UPR-MSC) 的妇产科和 相比之下，从 UPRMSC 两个妇产科诊所的参加者中选出了 100 名女性。 参与者将接受面对面采访，其中收集以下信息：人口统计 信息、吸烟和饮酒习惯、体重史、个人和家庭病史、生殖和 月经史、避孕和激素替代治疗史、不孕史以及 体力活动。此外，女性还将接受人体测量和血液采集 用于测量胰岛素抵抗的样品。胰岛素抵抗（IR）将使用定量测量 胰岛素敏感性检查指数（QUICKI）。此外，血清脂联素水平与胰岛素相关 抗性，将使用市售的定量夹心酶联法进行测量 免疫测定（ELISA）。单变量和多变量无条件逻辑回归模型将用于 评估子宫内膜癌与胰岛素抵抗和血清脂联素的关联。优势比 (OR) 及其 95% 置信区间将用于估计 IR 和 其他感兴趣的因素和子宫内膜癌。 标题：培训下一代西班牙裔癌症研究人员 抽象的 尽早招募代表性不足的少数群体参加生物医学和健康研究培训对于 确保这些职业体现社会的多样性。该提案的目的是加强 其合作伙伴有能力为显着增加代表性不足的少数群体的参与做出贡献 从事具有全国竞争力的癌症临床和基础研究。波多黎各大学 (UPR) 和 德克萨斯大学 MD 安德森癌症中心 (MDACC) 将继续开发全面的 从本科生到研究生的管道计划将增加西班牙裔学生的数量 知识渊博并致力于癌症研究和癌症医学的职业。本次活动的总体目标 该项目旨在鼓励西班牙裔科学和医学生从事癌症研究和 医学并充实 UPR 的教师队伍，以加强大学的癌症研究 波多黎各。波多黎各大学 (UPR) 正在与 MDACC 在多个领域开展培训计划 领域 - 生物医学和临床研究、教学、丰富经验、医学博士/博士学位。培训、研究生 临床培训、癌症预防和健康差异培训以及职业发展。想要的 结果将通过一系列协调一致的教学和研究经验和丰富来实现 活动包括波多黎各大学综合癌症中心的校园癌症研究 (UPRCCC) 在学年和夏季研究期间以及全年轮流到 MDACC。该计划 充分利用两个机构的优势，为双方带来好处。 标题：波多黎各社区癌症控制外展计划 抽象的 癌症是美国拉美裔人的第二大死亡原因。(1) 在过去十年中，西班牙裔人的癌症死亡率在某些癌症方面仍然存在差异。<2) 乳腺癌 宫颈癌和与烟草相关的癌症都属于其中。'113|4) 尽管吸烟率较低 与美国相比，波多黎各 (PR) 的烟草造成了巨大的公共健康负担，占总健康人数的 11.5% 波多黎各妇女死亡和 10% 的医疗保健费用可归因于吸烟。(4> 在 PR 中，乳腺癌是最常诊断的肿瘤（占所有癌症的 35%），也是导致乳腺癌的主要原因 癌症死亡（占总数的 15%）。(9) 宫颈癌是 PR 女性中第四大最常见的肿瘤， 占所有新诊断癌症的 4%，占所有癌症相关死亡的 2.4%。(9) 波多黎各社区癌症控制外展计划 (CCCOP) 的目的是修改和 通过发展全面、可持续的癌症伙伴关系来维持健康行为 控制波多黎各 (PR) 的外展、教育、研究和培训。具体来说，该计划的目的是 CCCOP 旨在减少烟草使用，增加针对人乳头瘤病毒 (HPV) 的疫苗接种，并增加 乳腺癌和宫颈癌筛查。 CCCOP 的计划组成部分将建立在合作的基础上， 外展试点项目中取得的基础设施、网络发展和外展成功。这 CCCOP 的具体目标是： 1. 维持、加强和进一步发展癌症控制外展活动 该网络将建立在现有关系的基础上，并在大学之间发展新的合作 波多黎各综合癌症中心 (UPRCCC)、德克萨斯大学 MD 安德森癌症中心 中心 (MDACC) 以及波多黎各主要社区和卫生组织； 2. 开展社区活动 乳腺癌和宫颈癌 (BCCS) 预防和筛查、烟草的需求和资源评估 控制并消除与这些癌症和行为相关的差异； 3.发展医疗保健 提供者和社区组织实施和维持具有文化能力的癌症控制的能力 旨在解决乳腺癌和宫颈癌以及烟草控制方面的差异的外展和教育计划； 4. 为 U54 研究人员和社区合作伙伴提供积极的指导和职业发展机会， 建设癌症控制和社区参与性研究的能力； 5. 评估影响 CCCOP 关于增加乳腺癌和宫颈癌筛查、增加 HPV 疫苗接种以及减少 公关中的烟草使用。 拟议的项目为 UPRCCC 和 MDACC 带来了好处，因为每个合作伙伴都带来了独特的专业知识 到伙伴关系。 CCCOP 还包括为癌症做好准备的主要职业发展组成部分 UPRCCC 和 MDACC 的差异研究员。 标题：生物统计学和生物信息学核心 抽象的 统计方法和理论的严格应用确保了研究的有效进行和 增加收集和正确解释有用数据的可能性。目的 生物统计学和生物信息学核心（BBC）旨在提供生物统计学和生物信息学方面的专业知识 合作伙伴内所有研究的生物信息学。调查人员将进行密切沟通 与BBC在项目的不同阶段合作，例如：研究设计、抽样设计、样本量、随机 分配、统计功效的确定、数据描述、数据建模、数据管理、质量 控制、数据库创建、跟踪数据库、合并文件、更新文件、数据编辑和归档， 以及缺失数据的检索。此外，为了改善我们与调查人员的沟通，BBC 计划组织与每项研究的统计需求相关的不同研讨会， 特别是回归模型（线性、逻辑、多水平）、生存分析、临床试验、样本量、 和功率的确定。此外，BBC人员将参与新统计数据的评估 癌症研究方法，特别是微阵列数据分析（McLachlan 等，2003）和遗传 流行病学（Suarez 等，2007）。