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OpenTrials
Completed

NCT Number: NCT06505746

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

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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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention

Other

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

Primary outcomes

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

    Time frame: Day 1

    Demographics of interest will be recorded.

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

    Time frame: Day 1

    Clinical characteristics of interest will be recorded.

  3. Therapies received at data collection and any therapies previously received for LA/mUC.

    Time frame: Day 1

    Details of current and previous therapies received for LA/mUC will be recorded.

Secondary outcomes

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

    Time frame: Day 1

    LA/mUC Healthcare resources will be recorded.

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

    Time frame: Day 1

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

  3. Current diagnostic tools in LA/mUC patients

    Time frame: Day 1

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

Sponsors and collaborators

Lead sponsor

Astellas Pharma Singapore Pte. Ltd.

Industry

Registry information

Official study title

Adelphi Real World Metastatic Urothelial Cancer Disease Specific Programme: Study of Real-world Data to Evaluate Patient Characteristics, Treatment Pattern and Healthcare Resource Utilisation of Locally Advanced or Metastatic Urothelial Cancer (La/mUC) at First-line Setting Post Avelumab Reimbursement in South Korea and Saudi Arabia

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 17, 2024
Registry last updated
Mar 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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