A Study of Real-world Treatment of Adults With Urothelial Cancer in South Korea and Saudi Arabia

NCT ID: NCT06505746

Last Updated: 2025-03-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 287 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-08-29
• Study Completion Date: 2025-01-31

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.

Conditions

Metastatic Urothelial Cancer

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: RETROSPECTIVE

Study Groups

LA/mUC patients

LA/mUC patient record-based survey of medical oncologists and urologists in Saudi Arabia and South Korea.

No intervention

Intervention Type: OTHER

No investigational drug will be administered to participants in this study.

Interventions

No intervention

No investigational drug will be administered to participants in this study.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Astellas Pharma Singapore Pte. Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Astellas Pharma Singapore Pte. Ltd.

Locations

KR00001

Seoul, , South Korea

Countries

South Korea

Other Identifiers

7465-MA-3515

Identifier Type: -

Identifier Source: org_study_id