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OpenTrials
Completed

NCT Number: NCT07386847

A Real-world Study of the First Treatment and Outcomes of Patients With Advanced or Metastatic Bladder Cancer

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:

* Were identified to have advanced or metastatic bladder cancer. * Started their first treatment after 01 Apr 2023. * Were 18 years of age or older when they were diagnosed with advanced disease.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Pfizer Office

New York, 10001, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adults (18 years or older) diagnosed with locally advanced or metastatic urothelial carcinoma (la/mUC) in the Flatiron Health database.
  • Started first line systemic treatment for la/mUC during the study period.
  • Received care in the United States, as the study is U.S.-based.
  • Has sufficient available real-world data to assess treatment patterns and outcomes (e.g., treatment dates, follow-up, response/survival information).

Exclusion criteria

  • Histology other than transitional cell (urothelial) carcinoma.
  • Primary site of disease other than bladder, renal pelvis, ureter, or urethra
  • Clinical trial participation.

Treatment and study plan

Primary outcomes

  1. Real world Progression Free Survival (rwPFS)

    Time frame: Up to 2 Years

    Time from initiation of first line treatment for la/mUC to the earliest of disease progression or death, based on real-world data sources.

Secondary outcomes

  1. Real world Overall Tumor Response (rwOTR)

    Time frame: Up to 2 Years

    Proportion of patients achieving tumor response (e.g., complete or partial response) based on real-world oncology data.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

Real-world Treatment Patterns and Effectiveness Among Patients With Locally Advanced or Metastatic Urothelial Carcinoma (la/mUC)

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 4, 2026
Registry last updated
May 28, 2026

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.

Published trials that share one or more normalized conditions with this study.