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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LA/mUC patients | LA/mUC patient record-based survey of medical oncologists and urologists in Saudi Arabia and South Korea. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention | Other | No investigational drug will be administered to participants in this study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Demographics associated with LA/mUC patients at various stages of treatment pathway | Demographics of interest will be recorded. | Day 1 |
| Clinical characteristics associated with LA/mUC patients at various stages of treatment pathway | Clinical characteristics of interest will be recorded. | Day 1 |
| Therapies received at data collection and any therapies previously received for LA/mUC. | Details of current and previous therapies received for LA/mUC will be recorded. | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Healthcare resource utilization of 1L and 2L+ LA/mUC patients | LA/mUC Healthcare resources will be recorded. | Day 1 |
| Current molecular/genetic testing patterns in LA/mUC patients | Tumor biomarker, genetic tests results and PD1/PD-L1 expression status will be recorded. |
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Inclusion Criteria:
Physician sample:
Patient sample:
Exclusion Criteria:
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LA/mUC patients being treated by medical oncologists and urologists in Saudi Arabia and South Korea. Patients will be sampled within a routine care setting in that they are consulting a physician through a pre-planned appointment.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Astellas Pharma Singapore Pte. Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KR00001 | Seoul | South Korea |
Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
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| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| Day 1 |
| Current diagnostic tools in LA/mUC patients | Tests and assessments used to diagnosis patient's LA/mUC will be recorded. | Day 1 |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |