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

NCT07386847 | Not Yet Recruiting

• 1 other identifier: C5701010
• Study Type: observational
• Target: 3,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Urothelial Cancer; Urothelial Carcinoma; Metastatic Urothelial Carcinoma; Locally Advanced or Metastatic Urothelial Carcinoma

Keywords

Metastatic Urothelial Carcinoma; Locally Advanced or Metastatic Urothelial Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Real-world Overall Tumor Response (rwOTR)

  Up to 2 Years

Study Arms (1)

la/mUC

Patients with Locally Advanced or Metastatic Urothelial Carcinoma (la/mUC) who received first line treatment.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Pfizer: lead

MeSH Terms

Conditions

Carcinoma, Transitional Cell

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Central Study Contacts

Pfizer CT.gov Call Center

CONTACT

1-800-718-1021; ClinicalTrials.gov_Inquiries@pfizer.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2026
• First Posted: February 4, 2026
• Study Start: January 30, 2026
• Primary Completion: March 1, 2026
• Study Completion: March 30, 2026
• Last Updated: February 4, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share