Metastatic Urothelial Cancer
Conditions
Keywords
Bladder cancer, LA/mUC
Brief summary
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.
Interventions
OTHERNo intervention
No investigational drug will be administered to participants in this study.
Sponsors
Astellas Pharma Singapore Pte. Ltd.
Study design
Observational model
OTHER
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Exclusion criteria
* Patients currently enrolled in a clinical trial * Patients participating in, or who have previously participated, in a clinical trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Demographics associated with LA/mUC patients at various stages of treatment pathway | Day 1 | Demographics of interest will be recorded. |
| Clinical characteristics associated with LA/mUC patients at various stages of treatment pathway | Day 1 | Clinical characteristics of interest will be recorded. |
| Therapies received at data collection and any therapies previously received for LA/mUC. | Day 1 | Details of current and previous therapies received for LA/mUC will be recorded. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Healthcare resource utilization of 1L and 2L+ LA/mUC patients | Day 1 | LA/mUC Healthcare resources will be recorded. |
| Current molecular/genetic testing patterns in LA/mUC patients | Day 1 | Tumor biomarker, genetic tests results and PD1/PD-L1 expression status will be recorded. |
| Current diagnostic tools in LA/mUC patients | Day 1 | Tests and assessments used to diagnosis patient's LA/mUC will be recorded. |
Countries
South Korea
Outcome results
None listed