跳至主要内容
临床试验/NCT03210298
NCT03210298Unknown不适用

Multicenter, International Online Documentation of Indications and Results of Pressurized IntraPeritoneal Aerosol Chemotherapy (PIPAC Und PITAC) for Treating Malignant Peritoneal and Pleural Diseases

Sabine Rhode15 个研究点 分布在 13 个国家目标入组 1,000 人开始时间: 2016年1月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
1,000
试验地点
15
主要终点
Overall survival

研究概览

简要总结

Multicentric, international, web-based prospective documentation of the indications and results of Pressurized Aerosol Chemotherapy (so-called PIPAC or PITAC) for treating malignant pleural and peritoneal diseases. Indication is decided by the treating physician. There are no predefined inclusion or exclusion criteria.

详细描述

All data entered into the registry documenting the patient cohort characteristics (disease, demography, therapy) are analyzed using descriptive statistics. Survival data are analyzed with Kaplan-Meier statistics. Multivariate Cox Proportional Hazard Models are used to identify potential prognostic and predictive factors. In particular, a risk- adjusted comparison of the outcome criteria with a propensity score is planned.

The data are stored in a SQL-based online database. Patient data are pseudoanonymized. The registry has received approval of the data protection officer of the State of Northrhine-Westphalia.

The study steering committee is blinded towards the identity of the participating institutions. Each participating institution receives an annual report with own data vs. benchmark. Scientific analysis can be proposed by the steering committee, by a participating institution or by other scientists, subjected to the approval of the independent scientific advisory board.

An export function has been built in to allow data exchange with the HIPEC Registry of the German Society for General and GI surgery (http://www.dgav.de/studoq/studoqhipec.html).

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
10 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Overall survival

时间窗: 1 to 5 years

Kaplan-Meier

次要结局

  • Clinical Benefit Rate(3 months)
  • Histological tumor regression according to the Peritoneal Regression Grading Score (PRGS)(6 weeks)
  • Safety according to CTCAE 4.0(6 weeks)
  • Quality of life according to QLQ-30 of EORTC(6-18 weeks)

研究者

发起方
Sabine Rhode
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Sabine Rhode

Coordinator

University of Magdeburg

研究点 (15)

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