CClinicalTrials.gg
CompletedNCT06505746Updated Mar 24, 2025

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

An observational study in Metastatic Urothelial Cancer, sponsored by Astellas Pharma Singapore Pte. Ltd.. Completed at 1 site in Korea, Republic of. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-24.

Sponsored by Astellas Pharma Singapore Pte. Ltd. · Observational

Study type
Observational
Model
Other
Time perspective
Retrospective
Enrollment
287
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Metastatic Urothelial Cancer

Keywords

  • Bladder cancer
  • LA/mUC
03

In context

Lead sponsor

Astellas Pharma Singapore Pte. Ltd. is the lead sponsor of 9 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

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

Exclusion Criteria:

  • Patients currently enrolled in a clinical trial
  • Patients participating in, or who have previously participated, in a clinical trial
05

Study design

Observational model
Other
Time perspective
Retrospective
Enrollment
287 participants (actual)
Patient registry
No

Groups and cohorts

  • LA/mUC patients

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

    Other: No intervention

Interventions

  • OtherNo intervention

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

06

What researchers measure

Primary outcomes

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

    Demographics of interest will be recorded.

    Time frame: Day 1

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

    Clinical characteristics of interest will be recorded.

    Time frame: Day 1

  3. 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.

    Time frame: Day 1

Secondary outcomes

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

    LA/mUC Healthcare resources will be recorded.

    Time frame: Day 1

  2. Current molecular/genetic testing patterns in LA/mUC patients

    Tumor biomarker, genetic tests results and PD1/PD-L1 expression status will be recorded.

    Time frame: Day 1

  3. Current diagnostic tools in LA/mUC patients

    Tests and assessments used to diagnosis patient's LA/mUC will be recorded.

    Time frame: Day 1

07

Study locations

1 site
  • KR00001
    Seoul, Korea, Republic of
08

References and documents

Individual participant data

Plan to share: No — 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/.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 24, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06505746
Lead sponsor
Astellas Pharma Singapore Pte. Ltd.
Responsible party
Sponsor
First posted
Jul 17, 2024
Start date
Aug 29, 2024
Primary completion
Jan 31, 2025
Completion
Jan 31, 2025
Last update
Mar 24, 2025

Study contacts

Medical Director
study director · Astellas Pharma Singapore Pte. Ltd.

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

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