ClinicalTrials.gg
Not yet recruitingNCT07897669Updated Oct 27, 2026

A Real-world Study to Learn About of the Characteristics and Outcomes of Advanced or Metastatic Bladder Cancer Patients With Different Histologies

An observational study in Metastatic Urothelial Carcinoma, Urothelial Cancer and Urothelial Carcinoma, sponsored by Pfizer. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-27.

Sponsored by Pfizer · Observational

Updated Oct 27, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
5,122
Ages
18 Years and older
Sex
All
01

Study 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.

When cancer develops, a pathologist examines a sample of the tumour under a microscope to see which cells the cancer started from. This is called the cancer's histology. Most bladder cancers begin in the cells that line the inside of the bladder and are called urothelial cancers. Less commonly, bladder cancer can develop from other cell types.

The purpose of this study is to examine the types of histology that adults with advanced or metastatic bladder cancer have. The researchers will also describe the demographics (information such as age, sex and race) clinical characteristics and outcomes of those patients.

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). to assess information for each participant for at least 6 months. 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.
02

Conditions studied

  • Metastatic Urothelial Carcinoma
  • Urothelial Cancer
  • Urothelial Carcinoma
  • Locally Advanced or Metastatic Urothelial Carcinoma
  • Bladder Cancer
  • Bladder Neoplasms
  • Bladder Tumors
  • Cancer of Bladder
  • Cancer of the Bladder
  • Malignant Tumor of Urinary Bladder
  • Neoplasms, Bladder
  • Urinary Bladder Cancer

Keywords

  • Metastatic Bladder Carcinoma
  • Locally Advanced or Metastatic Bladder Carcinoma
  • Variant histology
03

In context

Carcinoma, Transitional Cell

633 studies on the registry are indexed under Carcinoma, Transitional Cell; 181 are open to participants now.

This study's planned enrollment of 5,122 is above the median of 300 across 107 observational studies indexed under Carcinoma, Transitional Cell.

Browse Carcinoma, Transitional Cell studies →

Lead sponsor

Pfizer is the lead sponsor of 3,334 studies on the registry; 149 are open to participants now.

Of its 601 completed or terminated interventional studies of FDA-regulated products, 391 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

The study population includes adult patients in the United States diagnosed with locally advanced or metastatic bladder carcinoma (la/mBC) who initiated first line systemic treatment in the Flatiron Health database after 04/01/2023.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Adults (18 years or older) diagnosed with locally advanced or bladder cancer (la/mBC) in the Flatiron Health database.
  • Started systemic treatment for la/mBC during the study period.

Exclusion criteria

Exclusion Criteria:

  • Primary site of disease other than bladder, renal pelvis, ureter, or urethra
  • Clinical trial participation
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Line of therapy

A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.

“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.

05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
5,122 participants (estimated)

Groups and cohorts

  • la/mBC

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

06

What researchers measure

Primary outcomes

  1. Distribution of First-Line Treatment Regimens by Predominant Histology

    Number and percentage of participants receiving each type of first-line treatment, evaluated overall and stratified by predominant histology category.

    Time frame: Up to 2 Years

Secondary outcomes

  1. Real world Progression Free Survival (rwPFS)

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

    Time frame: Up to 2 Years

  2. Real world Overall Tumor Response (rwOTR)

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

    Time frame: Up to 2 Years

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No — 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.

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Oct 2026; primary completion for Apr 2027, 5 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 20, 2026
First posted
Oct 27, 2026
StartEst.
Oct 21, 2026
Primary completionEst.
Apr 1, 2027
CompletionEst.
Apr 1, 2027
Last update
Oct 27, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 27, 2026
Show all 1 update
  1. Oct 27, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07897669
Lead sponsor
Pfizer
Collaborators
Astellas Pharma Inc
Responsible party
Sponsor
First posted
Oct 27, 2026
Start date
Oct 21, 2026 (estimated)
Primary completion
Apr 1, 2027 (estimated)
Completion
Apr 1, 2027 (estimated)
Last update
Oct 27, 2026

Study contacts

Pfizer CT.gov Call Center
Contact
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021
Pfizer CT.gov Call Center
study director · Pfizer

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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