Clinical trial NCT06505746: A Study of Real-world Treatment of Adults With Urothelial Cancer in South Korea and Saudi Arabia
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metastatic Urothelial Cancer
Keywords: Bladder cancer
LA/mUC
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2024-07-17
Enrollment: 287
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
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.

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.


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

Primary outcomes:
measure: Demographics associated with LA/mUC patients at various stages of treatment pathway
timeFrame: Day 1
measure: Clinical characteristics associated with LA/mUC patients at various stages of treatment pathway
timeFrame: Day 1
measure: Therapies received at data collection and any therapies previously received for LA/mUC.
timeFrame: Day 1
Secondary outcomes:
measure: Healthcare resource utilization of 1L and 2L+ LA/mUC patients
timeFrame: Day 1
measure: Current molecular/genetic testing patterns in LA/mUC patients
timeFrame: Day 1
measure: Current diagnostic tools in LA/mUC patients
timeFrame: Day 1
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: KR00001
Study officials:
affiliation: Astellas Pharma Singapore Pte. Ltd.
name: Medical Director
role: STUDY_DIRECTOR
References: