Core C - Clinical Trials
核心 C - 临床试验
基本信息
- 批准号:10240535
- 负责人:
- 金额:$ 17.61万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2018
- 资助国家:美国
- 起止时间:2018-09-19 至 2023-08-31
- 项目状态:已结题
- 来源:
- 关键词:AdherenceAdverse eventAnnual ReportsAscorbic AcidBiological MarkersCase Report FormChemotherapy and/or radiationClinicalClinical Cancer CenterClinical DataClinical ResearchClinical TrialsClinical Trials Data Monitoring CommitteesCodeComplementComplexComprehensive Cancer CenterDataDevelopmentDoseEducationEligibility DeterminationEnsureEthicsGlioblastomaHumanHuman Subject ResearchInfrastructureInfusion proceduresInstitutional Review BoardsInstructionInvestigational DrugsInvestigational New Drug ApplicationIowaLungMalignant neoplasm of lungMalignant neoplasm of pancreasManuscriptsMetabolismMonitorNon-Small-Cell Lung CarcinomaOxidation-ReductionPancreasParticipantPatientsPeer ReviewPharmacologic AscorbatePhasePhase I/II TrialPreparationPrincipal InvestigatorProceduresProcessProtocols documentationPublicationsRadiationRadiation OncologyRadiation therapyReportingResearchResearch PersonnelResourcesSafetySamplingSiteStructureTrainingTraining ProgramsUniversitiesadverse outcomeascorbatebasebiomarker evaluationcancer therapychemotherapydesignexperiencegemcitabineimprovedin vivoinsightiron metabolismnovel therapeutic interventionpatient derived xenograft modelphase I trialphase II trialpreclinical studypredicting responseprogramsrecruitscreeningstandard of caretherapy outcometrial design
项目摘要
Project Summary/Abstract - Core C:
Core C will provide experienced, well-trained clinical trials staff specializing in implementing translational,
clinical research involving pharmacological ascorbate (P-AscH-). This group of clinical researchers has been
doing clinical trials for the past 10 years and has initiated as well as completed phase 1 and 2 trials using
P-AscH- combined with radiation and/or chemotherapy in pancreas, lung, and GBM subjects. Core C will
initiate, conduct, and complete all aspects of complex human subjects research with P-AscH- which are
proposed in Projects 1 and 2. Core C will also interface with Core B for patient sample acquisition and
processing, for biomarker evaluation as well as establishing a structured training program for staff participating
in each clinical trial research effort. This training program will include instruction in how to review processes for
eligibility determination as well as the review of ascorbate therapy infusions (including administration, review of
and contraindications) and adverse event reporting. In addition, Core C will provide expert guidance and
resources as well as interface with the Holden Comprehensive Cancer Center clinical trials infrastructure [(i.e.,
Protocol Review & Monitoring Committee (PRMC)/ Data and Safety Monitoring Committee (DSMC)] to identify
and report all key research data, and to design electronic case report forms for complete data capture, and to
ensure data veracity for ultimate result reporting to the FDA, and as well as in the preparation of peer-
reviewed publications.
项目摘要/摘要-核心C:
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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JOHN M. BUATTI其他文献
JOHN M. BUATTI的其他文献
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{{ truncateString('JOHN M. BUATTI', 18)}}的其他基金
Using Ketogenic Diets to Enhance Radio-Chemo-Therapy Response: A Phase I Trial
使用生酮饮食增强放射化疗反应:一期试验
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8333333 - 财政年份:2011
- 资助金额:
$ 17.61万 - 项目类别:
Using Ketogenic Diets to Enhance Radio-Chemo-Therapy Response: A Phase I Trial
使用生酮饮食增强放射化疗反应:一期试验
- 批准号:
8175225 - 财政年份:2011
- 资助金额:
$ 17.61万 - 项目类别:
Quantitative Imaging to Assess Response in Cancer Therapy Trials
定量成像评估癌症治疗试验中的反应
- 批准号:
8636907 - 财政年份:2010
- 资助金额:
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Quantitative Imaging to Assess Response in Cancer Therapy Trials
定量成像评估癌症治疗试验中的反应
- 批准号:
7891013 - 财政年份:2010
- 资助金额:
$ 17.61万 - 项目类别:
Quantitative Imaging to Assess Response in Cancer Therapy Trials
定量成像评估癌症治疗试验中的反应
- 批准号:
8456899 - 财政年份:2010
- 资助金额:
$ 17.61万 - 项目类别:
Quantitative Imaging to Assess Response in Cancer Therapy Trials
定量成像评估癌症治疗试验中的反应
- 批准号:
8244350 - 财政年份:2010
- 资助金额:
$ 17.61万 - 项目类别:
Quantitative Imaging to Assess Response in Cancer Therapy Trials
定量成像评估癌症治疗试验中的反应
- 批准号:
8964178 - 财政年份:2010
- 资助金额:
$ 17.61万 - 项目类别:
Quantitative Imaging to Assess Response in Cancer Therapy Trials
定量成像评估癌症治疗试验中的反应
- 批准号:
8034225 - 财政年份:2010
- 资助金额:
$ 17.61万 - 项目类别:
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