PHENOTYPING CORE

表型核心

• 批准号: 7725321
• 负责人: KENNETH WARD
• 金额: $ 17.81万
• 依托单位: UNIVERSITY OF HAWAII AT MANOA
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-07-01 至 2009-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7725321
• 关键词: Age-Years; Archives; Blood specimen; Cheek structure; Child; Clinical Data; Clinical Investigator; Clinical Research; Collection; Computer Retrieval of Information on Scientific Projects Database; Condition; Consent; Data; Databases; Discipline of obstetrics; Enrollment; Exclusion; Funding; Future; Grant; Health; High-Risk Pregnancy; Human Development; Human Resources; Inpatients; Institution; Laboratories; Laboratory Research; Measurement; Medical center; Midwife; Neonatal; Pathology; Patient currently pregnant; Patients; Perinatal; Phenotype; Physical Examination; Physicians; Placenta; Procedures; Process; Protocols documentation; Reading; Recruitment Activity; Research; Research Personnel; Research Subjects; Resources; Sampling; Source; Specimen; Standards of Weights and Measures; Swab; Techniques; Tissue Sample; Tissues; United States National Institutes of Health; Woman; clinical phenotype; follow-up; human subject; improved; neonate; repository; research study

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The Clinical Phenotype/Patient Sample Core will streamline access to clinical data and patient samples for the Pacific Research Center for Early Human Development (PRCEHD) investigators and other clinical investigators at JABSOM. The clinical phenotyping component of the Core consists of a new perinatal/neonatal database, a new placental bank, and the option for a standardized neonatal examination and improved neonatal follow-up capability. The patient sample component of this Core will provide ascertainment and recruitment of potential research subjects, ongoing collection of relevant specimens, efficient protocols to provide specimens and accompanying clinical data (as necessary) to investigators, and storage of materials in a sample repository. Finally, the core laboratory will offer basic and advanced pathology techniques to current and future projects. The specific aims of this Core are: 1) to build a new research database focused on perinatal and neonatal conditions, 2) to bank placental data and samples for all high-risk pregnancies for which standard pathological examinations were not requested by the attending physician or midwife, 3) to provide consistent and detailed physical examinations and anthropomorphic measurements on selected neonates, 4) to collect, access, archive, and distribute to the CCRE investigators high-quality tissue and blood specimens and relevant clinical data from obstetric and neonatal patients. This request for CRC personnel and facilities support is limited to the implementation of specific aim 4) (as listed above). The Core does not directly involve human subjects in experiments. The objective of this Core is to recruit all women delivering at Kapi'olani Medical Center for Women and Children (KMCWC). The Clinical Research Center's (CRC's) involvement in the study includes the collection of maternal blood samples or cheek swabs (similar to a Q-tip), cord blood samples, and placentas; and the transporting of these tissues to the JABSOM Clinical Phenotype/ Patient Sample Core Lab. All tissue samples and personal information will be securely maintained at the JABSOM Clinical Phenotype/Patient Sample Core laboratory for research use. All potential subjects will be pregnant, or recently delivered, inpatients at Kapi'olani Medical Center for Women and Children. The subjects will be 18-50 years of age, and will be able to read, speak and understand English. We will not include incarcerated women in this study. All subjects will be enrolled and consented prior to the collection of their personal health information and biomedical tissues. All subjects will be mentally competent to understand the consent process and the study procedures. There are no ethnic exclusions in this study. A record of ethnic background will be part of the patient database so that this factor can be analyzed.

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 临床表型/患者样本核心将简化太平洋人类早期发育研究中心(PRCEHD)的研究人员和JABSOM的其他临床研究人员对临床数据和患者样本的访问。CORE的临床表型部分包括一个新的围产期/新生儿数据库，一个新的胎盘库，以及标准化新生儿检查和改进的新生儿跟踪能力选项。这一核心的患者样本部分将提供潜在研究对象的确定和招募、相关样本的持续收集、向研究人员提供样本和附带临床数据(如有必要)的有效方案，以及样本储存库中的材料存储。最后，核心实验室将为当前和未来的项目提供基本和先进的病理学技术。该中心的具体目标是：1)建立一个以围产期和新生儿状况为重点的新的研究数据库；2)储存所有未经主治医生或助产士要求进行标准病理检查的高危妊娠的胎盘数据和样本；3)为选定的新生儿提供一致和详细的体检和人体测量；4)收集、获取、存档，并向CCRE调查员分发产科和新生儿患者的高质量组织和血液样本以及相关临床数据。 这项对儿童权利委员会人员和设施支持的请求仅限于执行具体目标4)(如上所述)。 核心不直接涉及实验中的人类受试者。这一核心的目标是招募所有在Kapi‘olani妇女和儿童医学中心分娩的妇女。临床研究中心(CRC)参与了这项研究，包括收集孕妇血液样本或面颊拭子(类似于Q-TIP)、脐带血样本和胎盘；并将这些组织转移到JABSOM临床表型/患者样本核心实验室。所有组织样本和个人信息将安全地保存在JABSOM临床表型/患者样本核心实验室，用于研究用途。所有潜在的受试者都将是Kapi‘olani妇女和儿童医学中心的孕妇或最近分娩的住院病人。受试者年龄在18-50岁之间，能够阅读、说和理解英语。我们不会把被监禁的女性包括在这项研究中。所有受试者将在收集其个人健康信息和生物医学组织之前进行登记和同意。所有受试者在精神上都有能力理解同意程序和研究程序。在这项研究中没有排除种族因素。种族背景记录将作为患者数据库的一部分，以便分析这一因素。