跳至主要内容
临床试验/NCT03560791
NCT03560791已完成不适用

A Review of Low-Dose CT Lung Cancer Screenings in a Community-Based Healthcare System With High Incidence

St Elizabeth Healthcare1 个研究点 分布在 1 个国家目标入组 7,659 人开始时间: 2018年4月6日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
7,659
试验地点
1
主要终点
Date(s) of LDCT

研究概览

简要总结

An analysis of Low-Dose Cat Scan(LDCT) Screenings for Lung Cancer completed within the St. Elizabeth system from January 2015 until December 2019. The study investigator, or designee(s), will retrospectively review patient encounters, collecting data related to LDCT referrals and completions. Data analysis will focus on the subsequent imaging, procedures, reviews at The Nodule Review Board and Lung Cancers diagnosed as a result of the LDCT.

详细描述

This study is a single center, minimal risk, physician initiated retrospective chart review. Potential subjects will be identified using records provided by the St. Elizabeth Healthcare Thoracic Oncology and Radiology Department. Potential subjects will be screened for eligibility. Study investigator and designees will review patient electronic medical records, extracting data related to the ordering/completion of a LDCT and interventions that occurs thereafter. Collected data will focus on dates of encounters, diagnostic imaging/procedures, and treatments. Please see Appendix A for a complete list of data points. All of the data that will be collected for study purposes will be kept confidential. This will be attained by the following: First, each enrolled subject will be assigned a study specific serial number for the database. All study documents and data collection tools will be maintained with the investigative site file in a locked cabinet in a secure location maintained by the investigator. The database will not include the patient's name or hospital medical record number. No one will have access to the database but the study principal investigator and study staff designated by the principal investigator. However, study data may be reviewed by the Institutional Review Board of record, an appointed study monitor, an internal auditor for St. Elizabeth Healthcare, and necessary regulatory authorities. The security of the database will be maintained under the direction of the principal investigator. Fourth, when the study is completed, the manuscript is published, and IRB storage document requirements have been met, the file will be permanently deleted and destroyed

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

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

  • Patients within St Elizabeth Healthcare who are referred for and/or have completed a LDCT from January 2015-February 2018
  • >=18 years of age

排除标准

  • Patient undergoes subsequent imaging, procedures and/or treatment at a facility outside of St. Elizabeth where records are not available through EPIC

结局指标

主要结局

Date(s) of LDCT

时间窗: From patient referral for LDCT to completion of screening up to 1 year

When the patient completed the LDCT(s)

次要结局

  • Additional Imaging caused by LDCTs(From patient referral through last radiographic image up to 6 years)
  • Additional Procedures caused by LDCTs(From evidence of concerning nodule through completion of treatment up to 6 years)
  • Adverse Events caused by LDCTs(From first screen through last treatment intervention for the nodule up to 6 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验

A Review of Low-Dose CT Lung Cancer Screenings in a... | 临床试验