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Bladder cancer (urothelial carcinoma) is a disease where cells in the bladder grow out of control. The bladder is an organ in the lower part of the body that stores urine. When someone has bladder cancer, abnormal cells form in the bladder and can spread to other parts of the body if not treated. Bladder cancer that has spread outside the bladder is called advanced or metastatic bladder cancer.
The purpose of this study is to examine how long it takes for adults with advanced or metastatic bladder cancer to experience worsening of their disease following their first treatment . The researchers will also describe which medicines these patients use as their first treatment for the disease.
This is a real-world study, not a clinical study. This means that researchers will look at what happens when patients receive the treatments prescribed by their own doctor as part of their usual healthcare treatment. In this study, researchers will use information from cancer clinics (Flatiron Health electronic health records). The study will include patients' information from the database who:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| la/mUC | Patients with Locally Advanced or Metastatic Urothelial Carcinoma (la/mUC) who received first line treatment. |
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| Measure | Description | Time Frame |
|---|---|---|
| Real world Progression Free Survival (rwPFS) | Time from initiation of first line treatment for la/mUC to the earliest of disease progression or death, based on real-world data sources. | Up to 2 Years |
| Measure | Description | Time Frame |
|---|---|---|
| Real world Overall Tumor Response (rwOTR) | Proportion of patients achieving tumor response (e.g., complete or partial response) based on real-world oncology data. | Up to 2 Years |
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Inclusion Criteria:
Exclusion Criteria:
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The study population includes adult patients in the United States diagnosed with locally advanced or metastatic urothelial carcinoma (la/mUC) who initiated first line systemic treatment in the Flatiron Health database after 04/01/2023.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Office | New York | New York | 10001 | United States |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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| ID | Term |
|---|---|
| D002295 | Carcinoma, Transitional Cell |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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