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

NCT06505746 | Completed

• 1 other identifier: 7465-MA-3515
• Study Type: observational
• Target: 287
• Locations: 1 country
• Sites: 1

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

Keywords

Bladder cancer; LA/mUC

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (3)

• Healthcare resource utilization of 1L and 2L+ LA/mUC patients

  Day 1

• Current molecular/genetic testing patterns in LA/mUC patients

  Day 1

• Current diagnostic tools in LA/mUC patients

  Day 1

Study Arms (1)

LA/mUC patients

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

Other: No intervention

Interventions

No intervention OTHER

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

LA/mUC patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Astellas Pharma Singapore Pte. Ltd.: lead

Study Sites (1)

KR00001

Seoul, South Korea

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Medical Director

  Astellas Pharma Singapore Pte. Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2024
• First Posted: July 17, 2024
• Study Start: August 29, 2024
• Primary Completion: January 31, 2025
• Study Completion: January 31, 2025
• Last Updated: March 24, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)