Metastatic Urothelial CancerNCT06505746
A Study of Real-world Treatment of Adults With Urothelial Cancer in South Korea and Saudi Arabia
An observational study of Metastatic Urothelial Cancer, run by Astellas Pharma Singapore Pte. Ltd. at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Urothelial Cancer
- How many people
- 287 participants
- Where
- 1 siteSouth Korea
- Study dates
- 29 Aug 2024to 31 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Show all 9Show fewer
- Patient sample:
- Confirmed/physician assessed diagnosis of LA/mUC
- Patient is not currently enrolled in a clinical trial
Who cannot join
- Patients currently enrolled in a clinical trial
- Patients participating in, or who have previously participated, in a clinical trial
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read more
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
- Being tested
- No intervention
- Keywords
- Bladder cancer, LA/mUC
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No investigational drug will be administered to participants in this study.
| Study group | Role | What they receive |
|---|---|---|
| LA/mUC patients | LA/mUC patient record-based survey of medical oncologists and urologists in Saudi Arabia and South Korea. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demographics associated with LA/mUC patients at various stages of treatment pathway
Demographics of interest will be recorded.
Measured: Day 1
Clinical characteristics associated with LA/mUC patients at various stages of treatment pathway
Clinical characteristics of interest will be recorded.
Measured: 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.
Measured: Day 1
Secondary outcomes (3)
Healthcare resource utilization of 1L and 2L+ LA/mUC patients
LA/mUC Healthcare resources will be recorded.
Measured: 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.
Measured: Day 1
Current diagnostic tools in LA/mUC patients
Tests and assessments used to diagnosis patient's LA/mUC will be recorded.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2024
- Study start29 Aug 2024
- Primary completion31 Jan 2025
- Study completion31 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Urothelial CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 287 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Singapore Pte. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Astellas Pharma Singapore Pte. Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06505746
- Sponsor's protocol ID
- 7465-MA-3515
- Status last verified
- Mar 2025
- First submitted
- 11 Jul 2024
- Last updated
- 24 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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/.
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06505746
- Acronym / sponsor ID
- 7465-MA-3515
- Conditions
- Metastatic Urothelial Cancer
- Keywords
- Bladder cancer, LA/mUC
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 287 participants (actual)
- Lead sponsor
- Astellas Pharma Singapore Pte. Ltd.Industry (pharma, biotech, devices)
- Study start
- 29 Aug 2024 (actual)
- Primary completion
- 31 Jan 2025 (actual)
- Study completion
- 31 Jan 2025 (actual)
- First posted
- 17 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LA/mUC patients | – | Other: No interventionLA/mUC patient record-based survey of medical oncologists and urologists in Saudi Arabia and South Korea. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (2 listed)
- Patients currently enrolled in a clinical trial
- Patients participating in, or who have previously participated, in a clinical trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo investigational drug will be administered to participants in this study. | Other | LA/mUC patients |
Primary outcome
Demographics associated with LA/mUC patients at various stages of treatment pathway
Time frame: Day 1
Demographics of interest will be recorded.
Clinical characteristics associated with LA/mUC patients at various stages of treatment pathway
Time frame: Day 1
Clinical characteristics of interest will be recorded.
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.
3 secondary outcomes
Healthcare resource utilization of 1L and 2L+ LA/mUC patients
Time frame: Day 1
Current molecular/genetic testing patterns in LA/mUC patients
Time frame: Day 1
Current diagnostic tools in LA/mUC patients
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2025.
- Individual participant dataSharing planned: 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/.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Astellas Pharma Singapore Pte. Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Urothelial Cancer, run by Astellas Pharma Singapore Pte. Ltd. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Demographics associated with LA/mUC patients at various stages of treatment pathway (time frame: Day 1). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2025.