CC: Clinical Research
CC:临床研究
基本信息
- 批准号:8719569
- 负责人:
- 金额:$ 18.41万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2013
- 资助国家:美国
- 起止时间:2013-09-12 至 2014-08-31
- 项目状态:已结题
- 来源:
- 关键词:AdherenceAdverse eventAdvocateAgeAgreementAmendmentBiohazardous SubstanceBiometryBiostatistics CoreBudgetsCancer CenterCancer Information ServiceCancer PatientCancer Therapy Evaluation ProgramCase Report FormClinicClinicalClinical ProtocolsClinical ResearchClinical TrialsClinical trial protocol documentCollaborationsComorbidityConfidentialityConsentConsent FormsDataData CollectionDatabasesDevelopmentDiagnosisDiscipline of NursingDiseaseDocumentationEducational MaterialsElementsEnrollmentEnsureEvaluationEventFundingFutureGoalsGuidelinesIndividualIndustryInstitutional Review BoardsIntranetK-Series Research Career ProgramsLabelLegalMaintenanceMalignant NeoplasmsMalignant neoplasm of pancreasMedicalMedical HistoryMedical RecordsMethodsModificationMonitorNorth Central Cancer Treatment GroupNotificationObservational StudyOnline SystemsPancreasPatient RecruitmentsPatientsPersonsPharmacy facilityPhasePhysiciansPrincipal InvestigatorProcessProgress ReportsProtocol ComplianceProtocols documentationQuality ControlRaceRadiationRecordsRecruitment ActivityRegistriesRegulationReportingResearchResearch ActivityResearch InfrastructureResearch PersonnelResearch Project GrantsResearch SupportResource SharingResourcesReview CommitteeRoleSafetySamplingSecureServicesSpecialistStandardizationSystemTelephoneTestingTimeTissuesTracerTrainingTranslational ResearchUnited States Food and Drug AdministrationUpdateWorkabstractingcareer developmentcase findingdesigndiabeticexperiencefollow-uphuman subjectinnovationmeetingsmemberpatient populationpatient registryprogramsprotocol developmentprotocol violationresearch and developmentsexvalidation studiesweb site
项目摘要
The Clinical Research Core is a newly created resource for the SPORE. It now combines the Patient
Registry activities that have been ongoing and supported by the SPORE in the previous funding period with
the new activities in the proposed funding period related to support for clinical studies in all four translational
research projects. The directors of this Core have extensive experience in studies of human subjects and
recruitment of patients to research protocols, both for observational studies and clinical trials. To date, the
pancreatic cancer SPORE'S Patient Registry activities have been very productive, with accrual of 2279
consented subjects (~325/year), using ultra-rapid case finding, a necessary method for this rapidly fatal
cancer. Mayo Clinic diagnoses and/or treats an estimated 570 pancreatic cancer patients per year across its
three campuses. There are 1612 pancreatic cancer patients in the Registry, of which >50% have pancreatic
tissue biospecimens accessioned in the Tissue Core. In addition, the Registry includes data on 1513 age,
sex, race, and region-matched healthy controls. It will coordinate its activities very closely with the
Biostatistics Core and the Tissue Core to ensure the highest quality annotated biospecimens and pancreatic
cancer database for research. The infrastructure for patient recruitment in the Registry will be used to recruit
subjects for Project 2. The SPORE will conduct early phase clinical trials in Projects 1, 3, and 4 in the next
funding period. It will utilize the Cancer Center-supported Clinical Research Office (CRO) shared resource to
operationalize the trials. The Clinical Research Core will 1) perform the necessary clinical trial management
support activities; 2) centrally coordinate all activities with the infrastructure of the Cancer Center CRO to
ensure smooth execution of the SPORE'S clinical trials; 3) perform all patient recruitment activities for the
triple tracer test for Project 2; 4) recruit new onset diabetics to support the validation study in Project 2; 5)
maintain the ultra-rapid case recruitment and registry of pancreatic cancer patients at all three Mayo
campuses; and 6) serve as a resource to future developmental research and career development research
projects. The close coordination and oversight of the most senior leaders of the SPORE will ensure that all
clinical research activities are performed with the highest level of research integrity and adherence to all
human subjects regulations.
临床研究核心是为SPORE新创建的资源。它现在结合了患者
在上一个资助期内一直在进行并得到SPORE支持的注册中心活动,
拟议资助期内的新活动涉及支持所有四个转化医学领域的临床研究,
研究项目。该中心的主任在人类受试者研究方面具有丰富的经验,
招募患者参与研究方案,包括观察性研究和临床试验。迄今为止
胰腺癌SPORE的患者登记活动非常富有成效,累计2279人
知情同意的受试者(约325例/年),使用超快速病例发现,这是快速致死性
癌马约诊所每年估计诊断和/或治疗570名胰腺癌患者
三个校园在登记处中有1612名胰腺癌患者,其中>50%患有胰腺癌。
组织核心中加入的组织生物标本。此外,登记册还包括15 - 13岁的数据,
性别、种族和地区匹配的健康对照。它将与联合国秘书长密切协调其活动,
生物统计学核心和组织核心,以确保最高质量的注释生物标本和胰腺
癌症数据库进行研究。登记研究中的患者招募基础设施将用于招募
项目2的主题。未来,SPORE将在项目1、3和4中进行早期临床试验。
融资期。它将利用癌症中心支持的临床研究办公室(CRO)共享资源,
进行审判临床研究中心将1)执行必要的临床试验管理
支持活动; 2)与癌症中心CRO的基础设施集中协调所有活动,
确保SPORE临床试验的顺利执行; 3)执行所有患者招募活动,
项目2的三重示踪剂试验; 4)招募新发糖尿病患者以支持项目2中的验证研究; 5)
在所有三个马约保持超快速病例招募和胰腺癌患者登记
校园;以及6)作为未来发展研究和职业发展研究的资源
项目SPORE最高级领导人的密切协调和监督将确保所有
临床研究活动是以最高水平的研究完整性和遵守所有
人体实验规定。
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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GLORIA M. PETERSEN其他文献
GLORIA M. PETERSEN的其他文献
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{{ truncateString('GLORIA M. PETERSEN', 18)}}的其他基金
The Exocrine and Endocrine Pancreas in Type 2 Diabetes, Pancreatitis and Cancer
2 型糖尿病、胰腺炎和癌症中的外分泌和内分泌胰腺
- 批准号:
10471570 - 财政年份:2021
- 资助金额:
$ 18.41万 - 项目类别:
Mayo Clinic Prospective Resource for Biomarker Validation and Early Detection of Pancreatic Cancer
梅奥诊所生物标志物验证和胰腺癌早期检测的前瞻性资源
- 批准号:
10427575 - 财政年份:2016
- 资助金额:
$ 18.41万 - 项目类别:
Mayo Clinic Prospective Resource for Biomarker Validation and Early Detection of Pancreatic Cancer
梅奥诊所生物标志物验证和胰腺癌早期检测的前瞻性资源
- 批准号:
9768973 - 财政年份:2016
- 资助金额:
$ 18.41万 - 项目类别:
Mayo Clinic Prospective Resource for Biomarker Validation and Early Detection of Pancreatic Cancer
梅奥诊所生物标志物验证和胰腺癌早期检测的前瞻性资源
- 批准号:
9352900 - 财政年份:2016
- 资助金额:
$ 18.41万 - 项目类别:
Mayo Clinic Prospective Resource for Biomarker Validation and Early Detection of Pancreatic Cancer
梅奥诊所生物标志物验证和胰腺癌早期检测的前瞻性资源
- 批准号:
9316574 - 财政年份:2016
- 资助金额:
$ 18.41万 - 项目类别:
The Exocrine and Endocrine Pancreas in Type 2 Diabetes, Pancreatitis and Cancer
2 型糖尿病、胰腺炎和癌症中的外分泌和内分泌胰腺
- 批准号:
10684464 - 财政年份:2015
- 资助金额:
$ 18.41万 - 项目类别:
The Exocrine and Endocrine Pancreas in Type 2 Diabetes, Pancreatitis and Cancer
2 型糖尿病、胰腺炎和癌症中的外分泌和内分泌胰腺
- 批准号:
10254446 - 财政年份:2015
- 资助金额:
$ 18.41万 - 项目类别:
The Exocrine and Endocrine Pancreas in Type 2 Diabetes, Pancreatitis and Cancer
2 型糖尿病、胰腺炎和癌症中的外分泌和内分泌胰腺
- 批准号:
10263461 - 财政年份:2015
- 资助金额:
$ 18.41万 - 项目类别:
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