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临床试验/NCT04334239
NCT04334239已完成不适用

Wirksamkeit Der Versorgung in Onkologischen Zentren

Technische Universität Dresden1 个研究点 分布在 1 个国家目标入组 670,000 人开始时间: 2017年5月1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
670,000
试验地点
1
主要终点
30-day mortality

研究概览

简要总结

Assessment of the effectiveness of care in certified cancer centres for eight cancer entities via a retrospective cohort study based on secondary data from statutory health insurance funds and population-based clinical cancer registries.

详细描述

Cancer constitutes the second most frequent cause of death in Germany. To maintain a high quality of treatment, the national cancer plan aims at a unified certification of cancer centres.

The project "Wirksamkeit der Versorgung in onkologischen Zentren" (WiZen) investigates effects of treatments in certified cancer centres across large populations and different cancer entities in comparison to hospitals that do not hold a certificate.

WiZen is a retrospective comparative cohort study that analyzes incident cases of eight types of cancer diagnosed within 2009-2017 based on nationwide health insurance data provided by WIdO (the AOK research institute) and data from regional clinical cancer registries (CCR) for the period 2006-2017. These eight types of cancer are colorectal cancer, pancreatic cancer, breast cancer, gynecologic tumors, lung cancer, prostate cancer, head and neck tumors and neuro-oncological tumors.

研究设计

研究类型
Observational
观察模型
Cohort
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

  • first hospitalization due to diagnosis of colorectal cancer, pancreatic cancer, breast cancer, gynecologic tumors, lung cancer, prostate cancer, head and neck tumors, or neuro-oncological tumors 2009-2017 [WIdO]
  • hospitalization due to primary diagnosis of colorectal cancer, pancreatic cancer, breast cancer, gynecologic tumors, lung cancer, prostate cancer, head and neck tumors, or neuro-oncological tumors 2006-2017 [CCR]

排除标准

  • prevalent diagnosis of colorectal cancer, pancreatic cancer, breast cancer, gynecologic tumors, lung cancer, prostate cancer, head and neck tumors, or neuro-oncological tumors 2006-2017
  • exception: outpatient cancer diagnosis up to 12 months prior to first hospitalization is not regarded as prevalent

结局指标

主要结局

30-day mortality

时间窗: first hospitalization (starting from 01/01/2009 [WIdO] or 01/01/2006 [CCR]) with 30 days follow-up

30-day mortality after first hospitalization due to cancer

Overall survival

时间窗: first hospitalization (starting from 01/01/2009 [WIdO] or 01/01/2006 [CCR]), up to 31/12/2017

Survival after first hospitalization due to cancer

1- and 5-year survival

时间窗: first hospitalization (starting from 01/01/2009 [WIdO] or 01/01/2006 [CCR]) with 1 or 5-year follow-up, respectively

1- and 5-year survival after first hospitalization due to cancer

次要结局

  • Pathways of treatment(2009-2017)
  • Recurrence-free survival(cancer diagnosis (starting from 01/01/2009 [WIdO] or 01/01/2006 [CCR]), up to 31/12/2017)
  • Complications due to surgery(date of initial cancer surgery with entity-specific follow-up)
  • 2-, 3-, 4-year survival(first hospitalization (starting from 01/01/2009 [WIdO] or 01/01/2006 [CCR]) with 2,3, or 4-year follow-up, respectively)
  • Cumulative recurrence rate(cancer diagnosis (starting from 01/01/2009 [WIdO] or 01/01/2006 [CCR]), up to 31/12/2017)
  • Successive resection(second resection within three months of initial cancer surgery)
  • Entity-specific outcomes defined by clinical experts(2009-2017 [CCR] or 2006-2017 [WIdO])
  • Severity Levels in insurance data(2009-2017)
  • Fraction of patients(2009-2017)
  • Regional differences(2009-2017)
  • Differences in patient characteristics(2009-2017 [CCR] or 2006-2017 [WIdO])

研究者

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

Jochen Schmitt.

Prof. Dr. med. Jochen Schmitt, MPH

Technische Universität Dresden

研究点 (1)

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