The Indiana University-Ohio State University Maternal and Pediatric Precision in Therapeutics Data, Model, Knowledge, and Research Coordination Center (IU-OSU MPRINT DMKRCC)

印第安纳大学-俄亥俄州立大学母婴精准治疗数据、模型、知识和研究协调中心 (IU-OSU MPRINT DMKRCC)

• 批准号: 10584124
• 负责人: Lang Li
• 金额: $ 97.48万
• 依托单位: INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-05-01 至 2023-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10584124
• 关键词: Advocate; Awareness; Bioethics Consultants; Biological; Biological Availability; Biological Markers; Biological Specimen Banks; Child; Childhood; Clinical Data; Clinical Management; Clinical Research; Collaborations; Communities; Consent Forms; Data; Databases; Development; Diagnosis; Disease; Evolution; Focus Groups; Foundations; Funding; Funding Agency; Future; Goals; Hand; Human Resources; Incidence; Indiana; Individual; Infrastructure; Interdisciplinary Study; Intervention; Knowledge; Legal; Link; Longitudinal Studies; Longterm Follow-up; Maternal and Child Health; Maternal complication; Modeling; Morbidity - disease rate; Mothers; Neonatal; Ohio; Outcome; Patients; Pediatric Research; Perinatal; Population; Pre-Eclampsia; Precision therapeutics; Pregnancy; Professional counselor; Rare Diseases; Regulation; Research; Research Personnel; Residual state; Resources; Risk; Sample Size; Sampling; Site; Source; Specimen; Surveys; Therapeutic; Therapeutic Human Experimentation; Therapeutic Studies; TimeLine; Translational Research; Translations; United States National Institutes of Health; Universities; Woman; Work; biobank; clinical phenotype; data dictionary; data integration; data repository; data resource; early onset; early pregnancy; fetal; high risk; innovation; mortality; novel therapeutic intervention; pediatric patients; perinatal period; pregnant; prevent; prospective; rare condition; recruit; repository; research study; response; translational scientist; user-friendly; web site; working group

Project Summary/Abstract Early-onset, or preterm, preeclampsia occurs in only 0.5% of pregnancies, but it is associated with a high risk of long- term maternal complications, as well as high fetal morbidity and mortality. Biomarkers associated with early-onset preeclampsia are needed to identify women at risk of developing early-onset preeclampsia, guide treatment options, and support development of new therapeutic approaches to prevent and treat the disease. Additionally, it is important to understand the long-term consequences of preterm preeclampsia in both the mother and child. However, due to the low incidence of early-onset preeclampsia, it is difficult to obtain data and necessary biospecimens from a sufficient number of women through a single center or study. Whether collected as a prospective biobanking endeavor or leftover residual samples from clinical studies, numerous biospecimens from maternal and pediatric patients reside within storage facilities across the world. These untapped biosamples and their associated data have the potential to greatly enhance maternal and pediatric therapeutics research, especially for rare conditions and diseases such as early-onset preeclampsia. However, there is no single resource to identify sources of maternal and pediatric biospecimens, so often translational researchers seeking such samples may not be aware of their existence. This proposal will characterize the landscape of available maternal and pediatric biospecimens and survey investigators to understand the needs of the translational research community. We will develop The Collaborative Online Perinatal & PEdiatric Repository (COPPER), a user-friendly platform to facilitate identification of biobanks and networks with residual biospecimens available to support maternal and pediatric precision therapy research. Through surveys and working group discussions, we will seek to understand the evolution of regulations relating to future use of biospecimens and propose strategies to enhance the ability to link long-term pediatric outcomes to samples collected during the perinatal period. At the end of this project, we will develop a centralized resource providing information on biorepositories which could support maternal and pediatric translational research and precision therapeutics, develop proposals to enhance the ability to link maternal and child data and specimens, and identify biospecimens and associated clinical data to support future work to develop biomarkers and therapeutic approaches to prevent and treat early-onset preeclampsia.

项目概要/摘要 早发型或早产子痫前期仅发生在 0.5% 的妊娠中，但它与长期妊娠的高风险相关。 足月孕产妇并发症以及胎儿高发病率和死亡率。与早发型相关的生物标志物 需要先兆子痫来识别有患早发性先兆子痫风险的女性，指导治疗选择， 并支持开发新的治疗方法来预防和治疗该疾病。此外，重要的是 了解早产先兆子痫对母亲和孩子的长期后果。然而，由于 早发性子痫前期的发生率较低，很难从足够的机构获得数据和必要的生物样本 通过单个中心或研究得出的女性人数。无论是作为前瞻性生物样本库工作还是剩余物收集 临床研究的残留样本，来自孕产妇和儿科患者的大量生物样本保存在 世界各地的存储设施。这些未开发的生物样本及其相关数据有可能极大地 加强孕产妇和儿科治疗研究，特别是针对早发等罕见病症和疾病 先兆子痫。然而，没有单一的资源来确定孕产妇和儿科生物样本的来源，因此通常 寻找此类样本的转化研究人员可能不知道它们的存在。该提案将描述 现有的孕产妇和儿科生物样本的情况以及调查研究人员的需求，以了解 转化研究社区。我们将开发在线协作围产期和儿科知识库 (COPPER)， 一个用户友好的平台，有助于识别生物库和网络，并提供剩余生物样本 支持母婴精准治疗研究。通过调查和工作组讨论，我们将寻求 了解与生物样本未来使用相关的法规的演变，并提出加强策略 能够将长期儿科结果与围产期收集的样本联系起来。在这个项目结束时， 我们将开发一个集中资源，提供有关生物储存库的信息，以支持孕产妇和 儿科转化研究和精准治疗，制定建议以增强与母亲联系的能力 以及儿童数据和样本，并识别生物样本和相关临床数据以支持未来的开发工作 预防和治疗早发性先兆子痫的生物标志物和治疗方法。