Metastatic Urothelial CarcinomaNCT07897669
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 of Metastatic Urothelial Carcinoma and Urothelial Cancer, run by Pfizer.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Urothelial Carcinoma, Urothelial Cancer, Urothelial Carcinoma
- How many people
- 5,122 participants
- Where
- No sites listed yet
- Study dates
- 21 Oct 2026to 1 Apr 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Adults (18 years or older) diagnosed with locally advanced or metastatic bladder cancer (la/mBC) in the Flatiron Health database.
- Started first line systemic treatment for la/mBC during the study period.
Who cannot join
- Primary site of disease other than bladder, renal pelvis, ureter, or urethra
- Clinical trial participation
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: CHARACTERISTICS AND OUTCOMES AMONG PATIENTS WITH DIFFERENT PREDOMINANT VARIANT HISTOLOGY TYPES OF LOCALLY ADVANCED OR METASTATIC BLADDER CARCINOMA (LA/MBC): A FLATIRON HEALTH REAL-WORLD STUDY
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.
Read more
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.
- Conditions
- Metastatic Urothelial Carcinoma, Urothelial Cancer, Urothelial Carcinoma, Locally Advanced or Metastatic Urothelial Carcinoma, Bladder Cancer, Bladder Neoplasms
- Keywords
- Metastatic Bladder Carcinoma, Locally Advanced or Metastatic Bladder Carcinoma, Variant histology
- Medical subject headings
- Carcinoma, Transitional Cell, Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| la/mBC | Patients with Locally Advanced or Metastatic Bladder Carcinoma (la/mBC) who received first line treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 2 Years
Secondary outcomes (2)
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.
Measured: Up to 2 Years
Real world Overall Tumor Response (rwOTR)
Proportion of patients achieving tumor response (e.g., complete or partial response) based on real-world oncology data.
Measured: Up to 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study start21 Oct 2026 (estimated)
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Urothelial CarcinomaStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 5,122 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Astellas Pharma Inc
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07897669
- Sponsor's protocol ID
- C5701011
- Status last verified
- Oct 2026
- First submitted
- 20 Oct 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CHARACTERISTICS AND OUTCOMES AMONG PATIENTS WITH DIFFERENT PREDOMINANT VARIANT HISTOLOGY TYPES OF LOCALLY ADVANCED OR METASTATIC BLADDER CARCINOMA (LA/MBC): A FLATIRON HEALTH REAL-WORLD STUDY
- ClinicalTrials.gov ID
- NCT07897669
- Acronym / sponsor ID
- C5701011
- Conditions
- Metastatic Urothelial Carcinoma, Urothelial Cancer, Urothelial Carcinoma, Locally Advanced or Metastatic Urothelial Carcinoma, Bladder Cancer, Bladder Neoplasms
- Keywords
- Metastatic Bladder Carcinoma, Locally Advanced or Metastatic Bladder Carcinoma, Variant histology
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 5,122 participants (estimated)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Collaborators
- Astellas Pharma Inc
- Study start
- 21 Oct 2026 (estimated)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 27 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| la/mBC | – | –Patients with Locally Advanced or Metastatic Bladder Carcinoma (la/mBC) who received first line treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Adults (18 years or older) diagnosed with locally advanced or metastatic bladder cancer (la/mBC) in the Flatiron Health database.
- Started first line systemic treatment for la/mBC during the study period.
Key exclusion criteria (2 listed)
- Primary site of disease other than bladder, renal pelvis, ureter, or urethra
- Clinical trial participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Distribution of First-Line Treatment Regimens by Predominant Histology
Time frame: Up to 2 Years
Number and percentage of participants receiving each type of first-line treatment, evaluated overall and stratified by predominant histology category.
2 secondary outcomes
Real world Progression Free Survival (rwPFS)
Time frame: Up to 2 Years
Real world Overall Tumor Response (rwOTR)
Time frame: Up to 2 Years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pfizer CT.gov Call Center study director
Pfizer
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Urothelial Carcinoma and Urothelial Cancer, run by Pfizer.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pfizer CT.gov Call Center (1-800-718-1021, ClinicalTrials.gov_Inquiries@pfizer.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Distribution of First-Line Treatment Regimens by Predominant Histology (time frame: Up to 2 Years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.