Data Coordinating Center for the Type 1 Diabetes in Acute Pancreatitis Consortium
急性胰腺炎联盟 1 型糖尿病数据协调中心
基本信息
- 批准号:10672905
- 负责人:
- 金额:$ 389.57万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2020
- 资助国家:美国
- 起止时间:2020-09-17 至 2025-07-31
- 项目状态:未结题
- 来源:
- 关键词:AccountabilityAcuteAdherenceAdverse eventAgreementAncillary StudyAreaAutoantibodiesAutoimmune ProcessBiologicalBiological FactorsBiological MarkersClinicalClinical TrialsCollaborationsCollectionCommon Data ElementConflict of InterestContractsDataData AnalysesData CollectionData Coordinating CenterData Management ResourcesData SetDevelopmentDevicesDiabetes MellitusDisease ProgressionDocumentationElectronic Health RecordEndocrinologyEnrollmentEnsureEnvironmental Risk FactorEthnic OriginEtiologyFriendsFunctional disorderFundingGastroenterologyGeneticGenomicsGeographyGrantHealthHealth Insurance Portability and Accountability ActHealth SciencesImmuneIncidenceInflammatoryInformation DisseminationInfrastructureInstitutional Review BoardsInsulin-Dependent Diabetes MellitusInternetLaboratoriesLearningLongitudinal, observational studyManuscriptsMedicalMedicineMonitorMulti-Institutional Clinical TrialNational Institute of Diabetes and Digestive and Kidney DiseasesObservational StudyPancreasPancreatitisParentsPatientsPennsylvaniaPersonsPopulation HeterogeneityPredispositionPreparationProceduresProcessProtocols documentationPublic HealthPublicationsQualifyingQuality ControlRandomizedRecording of previous eventsReportingResearch DesignResearch PersonnelRiskRisk FactorsRoleSafetySafety ManagementSample SizeSamplingSecurityServicesSeveritiesSite VisitStatistical Data InterpretationSubgroupSupport SystemSystemTestingTherapeuticTimeUnited States National Institutes of HealthUniversitiesValidationVertebral columnVisitacute pancreatitisbiobankbiomarker developmentclinical centercohortcollegecomorbiditycostdata exchangedata managementdata standardsdata submissiondrug distributionearly detection biomarkersexpectationexperiencegenetic risk factorimpaired glucose toleranceinsightmultidisciplinarynovelparticipant enrollmentpotential biomarkerprogramsprospectivequality assurancerecruitresearch studyresponseuser-friendlyweb site
项目摘要
ABSTRACT
Type 1 diabetes mellitus (T1D) may develop after, or as a consequence of, one or more acute pancreatitis
episodes. Elucidation of early biomarkers, clinical signs, biomarkers of disease progression, immune and
genetic risk factors, most susceptible subgroups, precipitating mechanisms, etiology of acute pancreatitis, and
associated pathophysiology of the T1D can help inform best practices in treatment for reducing incidence of
T1D onset. In response to the National Institute of Diabetes and Digestive and Kidney Diseases’ RFA-DK-19-
023, the Departments of Public Health Sciences (DPHS) and Medicine (Endocrinology and Gastroenterology)
at The Pennsylvania State University College of Medicine and the Allegheny Health Network propose to serve
as the Data Coordinating Center (DCC) for the Type 1 Diabetes in Acute Pancreatitis Consortium (T1DAPC).
One DCC and 10 Clinical Centers (RFA-DK-19-022) will form the clinical consortium, T1DAPC. An efficient and
supportive DCC not only collaborates on development of all documentation and provides efficient statistical
analyses and Trial Master File, the results from the DCC form the backbone of numerous publications,
preliminary data for subsequent trials, and may lead to profound novel insights from ad-hoc, post-hoc, and
newly formulated analyses to Questions arising during the study. DPHS has vast experience and expertise as
the DCC for 10 NIH-funded clinical trial and five observational study research networks, which resulted in more
than 200 publications, six subsequent grants. Our vast experience in DCC for HIPAA-compliant data
compilation and analyses of multicenter clinical trials spans more than a dozen therapeutic areas and can
provide additional insights for analysis of ethnically and geographically diverse population of subjects as well
as development and analyses of distinct and overlapping clinical profiles, some being instituted post hoc with
development and testing cohorts. The DCC will aggregate and analyze all common data elements and
samples and provide scientific infrastructure and administrative support in a clear, concise, friendly manner for
the T1DAPC Consortium. The DCC and the Clinical Centers will form multi-disciplinary teams that execute a
prospective longitudinal observational study that can determine the incidence of T1 diabetes associated with
an acute pancreatitis episode and assess relationships with potential early biomarkers, clinical signs,
biomarkers of disease progression, immune and genetic risk factors, most susceptible subgroups, precipitating
mechanisms, etiology of acute pancreatitis, and associated pathophysiology of the T1D or other types of
diabetes. The DCC will collect, synthesize, and disseminate main findings and lessons learned from the
T1DAPC parent and ancillary studies, create public data sets, and share the biological samples in accordance
with the NIDDK and T1DAPC.
摘要
1型糖尿病(T1 D)可能在一次或多次急性胰腺炎后发生,或作为其结果发生
情节。阐明早期生物标志物、临床体征、疾病进展的生物标志物、免疫和
遗传风险因素、最易感亚组、诱发机制、急性胰腺炎病因,以及
T1 D的相关病理生理学可以帮助提供治疗的最佳实践,以降低T1 D的发病率。
T1 D发作。为了响应国家糖尿病、消化和肾脏疾病研究所的RFA-DK-19-
023,公共卫生科学系(DPHS)和医学系(内分泌学和胃肠病学)
宾夕法尼亚州立大学医学院和阿勒格尼健康网络提出,
作为1型糖尿病急性胰腺炎联盟(T1 DAPC)的数据协调中心(DCC)。
一个DCC和10个临床中心(RFA-DK-19-022)将组成临床联盟T1 DAPC。高效和
支持性的DCC不仅在所有文件的编制方面进行合作,
分析和试验主文件,DCC的结果构成了许多出版物的支柱,
初步数据,为后续试验,并可能导致深刻的新见解,从特设,事后,
对研究过程中出现的问题进行新的分析。DPHS拥有丰富的经验和专业知识,
DCC为10个NIH资助的临床试验和5个观察性研究网络,这导致了更多
200多篇出版物,6次后续赠款。我们在符合HIPAA的数据DCC方面的丰富经验
多中心临床试验的汇编和分析跨越十几个治疗领域,
还为分析受试者的种族和地理多样性提供了更多见解
作为不同和重叠的临床特征的开发和分析,有些是事后制定的,
开发和测试队列。DCC将汇总和分析所有通用数据元素,
样品,并以清晰、简洁、友好的方式提供科学基础设施和行政支持,
T1 DAPC联盟DCC和临床中心将组成多学科团队,
一项前瞻性纵向观察性研究,可以确定与以下因素相关的T1糖尿病的发病率:
急性胰腺炎发作,并评估与潜在的早期生物标志物,临床体征,
疾病进展的生物标志物,免疫和遗传风险因素,最易感亚组,
急性胰腺炎的发病机制、病因学以及T1 D或其他类型胰腺炎的相关病理生理学,
糖尿病发展协调委员会将收集、综合和传播
T1 DAPC母研究和辅助研究,创建公共数据集,并根据
NIDDK和T1 DAPC。
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
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Vernon M Chinchilli其他文献
Estrogen or Testosterone Increases Facial and Body Attractiveness in Hypogonadal Adolescents 13
- DOI:
10.1203/00006450-199804001-00034 - 发表时间:
1998-04-01 - 期刊:
- 影响因子:3.100
- 作者:
Jennifer Neuffer;Glenn Cohen;Steven Foreman;Howard E Kulin;Elizabeth J Susman;Vernon M Chinchilli;Susan J Kunselman;Lynn S Liben;Jacqueline Schwab;Lawrence M Demers;M Rose D'Arcangelo;Traci Wojtkowski;Daniela E Rusovici;Jordan W Finkelstein - 通讯作者:
Jordan W Finkelstein
The epidemiology of berry consumption and association of berry consumption with diet quality and cardiometabolic risk factors in US adults: the National Health and Nutrition Examination Survey, 2003-2018.
美国成年人浆果消费的流行病学以及浆果消费与饮食质量和心脏代谢危险因素的关联:2003-2018 年国家健康和营养检查调查。
- DOI:
- 发表时间:
2024 - 期刊:
- 影响因子:0
- 作者:
Li Zhang;Joshua E Muscat;Penny M. Kris;Vernon M Chinchilli;Laila Al;John P. Richie - 通讯作者:
John P. Richie
Hematologic manifestations of systemic mast cell disease: a prospective study of laboratory and morphologic features and their relation to prognosis.
系统性肥大细胞疾病的血液学表现:实验室和形态学特征及其与预后关系的前瞻性研究。
- DOI:
- 发表时间:
1991 - 期刊:
- 影响因子:5.9
- 作者:
Jeffry B. Lawrence;B. S. Friedman;William D. Travis;Vernon M Chinchilli;Vernon M Chinchilli;D. Metcalfe;Harvey R. Gralnick - 通讯作者:
Harvey R. Gralnick
Vernon M Chinchilli的其他文献
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{{ truncateString('Vernon M Chinchilli', 18)}}的其他基金
The Biostatistics Research Center for the Impaired Awareness of Hypoglycemia Consortium
低血糖意识障碍联盟生物统计学研究中心
- 批准号:
10599379 - 财政年份:2022
- 资助金额:
$ 389.57万 - 项目类别:
Data Coordinating Center for the Type 1 Diabetes in Acute Pancreatitis Consortium
急性胰腺炎联盟 1 型糖尿病数据协调中心
- 批准号:
10907944 - 财政年份:2020
- 资助金额:
$ 389.57万 - 项目类别:
Data Coordinating Center for the Type 1 Diabetes in Acute Pancreatitis Consortium
急性胰腺炎联盟 1 型糖尿病数据协调中心
- 批准号:
10461052 - 财政年份:2020
- 资助金额:
$ 389.57万 - 项目类别:
Data Coordinating Center for the Type 1 Diabetes in Acute Pancreatitis Consortium
急性胰腺炎联盟 1 型糖尿病数据协调中心
- 批准号:
10471067 - 财政年份:2020
- 资助金额:
$ 389.57万 - 项目类别:
Data Coordinating Center for the Type 1 Diabetes in Acute Pancreatitis Consortium
急性胰腺炎联盟 1 型糖尿病数据协调中心
- 批准号:
10265554 - 财政年份:2020
- 资助金额:
$ 389.57万 - 项目类别:
Novel statistical methods for controlled variable selection of microbiome data
微生物组数据受控变量选择的新统计方法
- 批准号:
10116262 - 财政年份:2020
- 资助金额:
$ 389.57万 - 项目类别:
Ambulatory Methods for Measuring Cognitive Change
测量认知变化的流动方法
- 批准号:
10213642 - 财政年份:2018
- 资助金额:
$ 389.57万 - 项目类别:
Ambulatory Methods for Measuring Cognitive Change
测量认知变化的流动方法
- 批准号:
10426148 - 财政年份:2018
- 资助金额:
$ 389.57万 - 项目类别:
Data Coordinating Center for the Natural History of AKI Consortium
AKI 联盟自然历史数据协调中心
- 批准号:
7687205 - 财政年份:2008
- 资助金额:
$ 389.57万 - 项目类别:
Data Coordinating Center for the Natural History of AKI Consortium
AKI 联盟自然历史数据协调中心
- 批准号:
8143961 - 财政年份:2008
- 资助金额:
$ 389.57万 - 项目类别:
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