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临床试验/NCT05074537
NCT05074537进行中(未招募)不适用

The WIIA - The Wright Center of Innovation Imaging Archive

University of Cincinnati1 个研究点 分布在 1 个国家目标入组 10,000 人开始时间: 2019年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
10,000
试验地点
1
主要终点
Anatomic Variability - Length

研究概览

简要总结

This data bank will serve as a data resource for a multidisciplinary team of clinicians and basic scientists. Specifically, this data bank will allow investigators to generate preliminary data for competitive consideration in intermural and extramural funding while enabling advanced analytical tool development and deep learning methodologies. This effort will enable the use for leading edge innovation in biomedical imaging by using clinical imaging studies that otherwise could not be used for such developments. We aim to use these data to improve diagnostics and disease management. With this data bank, we hope to improve the quality of imaging and the precision of imaging based analytics to better detect potential health risks, predict treatment response, and monitor disease progression in order to guide management of future patients.

详细描述

The constant advances in computational capabilities and abilities of deep learning necessitate the availability of large imaging data sets that can be further analyzed. We therefore create the WIIA - The Wright Center of Innovation Imaging Archive - to serve as a repository for advanced data analytics and simulation. This will provide researchers access to a robust, comprehensive pool of imaging data for impactful research. The patient population under study includes adults who are 18 years of age and older. Children will be excluded from this study as they are unable to give voluntary consent. A partial waiver of HIPAA authorization will be requested to permit access to and use of PHI for recruitment purposes. However, investigational data will only be collected once consent to participate in the study is acquired. There will be no upper limit to the number of people who participate in this study. We expect 100-150 participants per year, with plans for the study to continue indefinitely. Data collected will include coded demographics, abbreviated medical history, current diagnoses, coded medical reports, coded surgical/nonsurgical treatment procedures, and follow up information. These data will be collected from Standard of Care (SOC) or investigational imaging studies. These data will be coded and stored in the Wright Center of Innovation Imaging Archive, which is a secure database of imaging studies. Data will be stored indefinitely. Administrative staff will construct and maintain the database as well as conduct annual quality assurance assessments of bank data. Oversight of the bank will be the responsibility of the Principal and Co-Investigators of the study. To maximize the use of this data bank and to promote collaborative, multi-institutional research, we are not limiting future data use. Data may be shared with Ohio State or non-Ohio State researchers. However, only investigators with sound, hypothesis driven research proposals can request data by completing a Data Request Form. This study will impose minimal medical risk to participants. At data leak is the primary risk, which will be minimized through precautions to protect PHI. Nevertheless, in the event of a data breach, the nature of the collected data ensures minimal financial or professional impact on the patient. This study does not confer a direct benefit to the patient. However, society may benefit from imaging advancements that arise from future studies using this data.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient provides consent
  • Patient is receiving or has received a SOC or investigational imaging scan

排除标准

  • Patient does not wish to or is unable to provide consent
  • Patient is below the age of 18

结局指标

主要结局

Anatomic Variability - Length

时间窗: through study completion (roughly 10 years)

Image quality

时间窗: through study completion (roughly 10 years)

We will be assessing image quality using a likert scale

Anatomic Variability - Volume

时间窗: through study completion (roughly 10 years)

Anatomic Variability - Density

时间窗: through study completion (roughly 10 years)

Anatomic Variability - Likert Scale

时间窗: through study completion (roughly 10 years)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Michael V Knopp MD PhD

Professor

University of Cincinnati

研究点 (1)

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