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临床试验/NCT06505746
NCT06505746已完成不适用

Adelphi Real World Metastatic Urothelial Cancer Disease Specific Programme: Study of Real-world Data to Evaluate Patient Characteristics, Treatment Pattern and Healthcare Resource Utilisation of Locally Advanced or Metastatic Urothelial Cancer (La/mUC) at First-line Setting Post Avelumab Reimbursement in South Korea and Saudi Arabia

Astellas Pharma Singapore Pte. Ltd.1 个研究点 分布在 1 个国家目标入组 287 人开始时间: 2024年8月29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
287
试验地点
1
主要终点
Demographics associated with LA/mUC patients at various stages of treatment pathway

研究概览

简要总结

Cancer in the bladder lining (urothelial cancer) can be treated in many ways. One way is to directly attack cancer cells. Enfortumab vedotin is a treatment that can do this. Another way is to help the body's immune system find and attack cancer cells. Avelumab is a treatment that can do this. Both treatments were recently approved in some countries.

Doctors have standard clinical practice guidelines to help them treat people with cancer. This study is about collecting information on how adults with urothelial cancer are treated in standard clinical practice. The people in this study will have locally advanced or metastatic urothelial cancer. Locally advanced means the cancer has spread to tissue close by.

Metastatic means the cancer has spread to other parts of the body.

The goal of this study is to learn how people with urothelial cancer receive medical care in clinics in South Korea and Saudi Arabia. The main goals are to learn more about the people receiving treatments, and the treatments they receive.

This study is about collecting information only. The individual's doctor decides on treatment, not the study sponsor (Astellas).

Information will be collected from the people's medical records. This will include 12 months before treatment starts, and during treatment. Also, doctors will answer questions in interviews and surveys about how they care for people with urothelial cancer.

研究设计

研究类型
Observational
观察模型
Other
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

  • Physician sample:
  • Medical oncologist or urologist (Medical oncologists only in Saudi Arabia. A minimum of 15 medical oncologists in South Korea, increased where possible, with the remaining sample consisting of urologists)
  • Personally responsible for treatment and management of LA/mUC patients
  • At least 50 percent of time spent in management of patients
  • See a minimum of 4 LA/mUC patients per month
  • Accept all survey rules and requirements
  • Patient sample:
  • Confirmed/physician assessed diagnosis of LA/mUC
  • Patient is not currently enrolled in a clinical trial

排除标准

  • Patients currently enrolled in a clinical trial
  • Patients participating in, or who have previously participated, in a clinical trial

结局指标

主要结局

Demographics associated with LA/mUC patients at various stages of treatment pathway

时间窗: Day 1

Demographics of interest will be recorded.

Clinical characteristics associated with LA/mUC patients at various stages of treatment pathway

时间窗: Day 1

Clinical characteristics of interest will be recorded.

Therapies received at data collection and any therapies previously received for LA/mUC.

时间窗: Day 1

Details of current and previous therapies received for LA/mUC will be recorded.

次要结局

  • Current molecular/genetic testing patterns in LA/mUC patients(Day 1)
  • Healthcare resource utilization of 1L and 2L+ LA/mUC patients(Day 1)
  • Current diagnostic tools in LA/mUC patients(Day 1)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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