Urinary Bladder NeoplasmsBRITENCT07784387
A Study to Characterize High-Risk Non-Muscle-Invasive Bladder Cancer Participants in Portugal
An observational study of Urinary Bladder Neoplasms, run by Janssen-Cilag Farmaceutica Ltda. at 1 site in Portugal.
Trial summary
The purpose of this study is to understand how the participants with high-risk non-muscle invasive bladder cancer are diagnosed, treated, and cared for in regular clinical practice in Portugal. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Bladder Neoplasms
- How many people
- 250 participants
- Where
- 1 sitePortugal
- Study dates
- 25 Aug 2026to 25 Feb 2028
- 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 the participants from Portuguese hospitals that treat and manage High-Risk Non-Muscle Invasive Bladder Cancer (HR-NMIBC) in routine clinical practice.
Who may be able to join
- Bladder cancer diagnosis between January 1, 2016 and December 31, 2020
- Tumor stage N0/x and M0/x plus any of the following: Tis (primary CIS); TaG3/HG (high-grade non-invasive papillary carcinoma); or T1 (tumor invading subepithelial connective tissue)
- Minimal follow-up time of 5 years unless there is premature death event
Who cannot join
- Tumor stage at diagnosis classified as TaG1-2, T2-T4, N1-3, or M1
- History of radical cystectomy performed either prior to the HR-NMIBC index diagnosis or for an indication unrelated to the index HR-NMIBC
- Participation in any interventional clinical trial during the observation period
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: High-Risk Non-Muscle-Invasive Bladder Cancer (HR-NMIBC) Retrospective Cohort Study
The purpose of this study is to understand how the participants with high-risk non-muscle invasive bladder cancer are diagnosed, treated, and cared for in regular clinical practice in Portugal. HR-NMIBC is an early-stage bladder cancer that is limited to the inner lining of bladder but has a considerable high chance of cancer coming back or worsening.
- Conditions
- Urinary Bladder Neoplasms
- Medical subject headings
- 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 |
|---|---|---|
| HR-NMIBC Participants: Portuguese Routine Practice | Participants diagnosed with high-risk non-muscle-Invasive bladder cancer (HR-NMIBC) in Portugal between January 1, 2016 and December 31, 2020, with tumor stage N0/x and M0/x and one of the following: Tis (primary CIS), TaG3/HG, or T1 will be enrolled. Demographic and clinical information will be gathered from both electronic and paper records for each participant. Only data available within routine clinical practice from the diagnosis until, at least, 5 years after diagnosis will be collected in this study. No drug will be administered as a part of this study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Patterns: Type of Therapeutic Approach
Number of participants receiving different types of therapeutic approach including bacillus calmette-guerin (BCG) therapy, chemotherapy, radiotherapy, immunotherapy, or targeted therapy will be reported.
Measured: Up to 5 years
Treatment Patterns: Type of Surgery
Number of participants undergoing different types of surgery, including transurethral resection of the bladder tumor (TURBT), repeat TURBT or cystectomy will be reported.
Measured: Up to 5 years
Treatment Patterns by Subpopulation: Tumor Stage
Number of participants by tumor stage will be reported.
Measured: Up to 5 years
Treatment Patterns by Subpopulation: Histology
Number of participants by histology will be reported.
Measured: Up to 5 years
Treatment Patterns by Subpopulation: Line of Therapy
Number of participants by line of therapy will be reported,
Measured: Up to 5 years
Secondary outcomes (12)
Total Number of BCG Doses Administered
Total number of BCG doses administered will be reported.
Measured: Up to 5 years
Percentage of Participants With BCG Non-Responsive Disease
Percentage of participants with BCG non-responsive disease will be reported. This is defined as being one of the following: a) Persistent or recurrent carcinoma in situ (CIS) alone or with recurrent Ta/T1 (noninvasive papillary disease/tumor invades the subepithelial connective tissue) disease within 12 months of completion of adequate BCG therapy (defined as at least 5 of 6 induction doses, plus at least 2 of 3 maintenance doses or a second induction). b) Recurrent high-grade Ta/T1 disease within 6 months of completion of adequate BCG therapy. c) T1 high-grade disease at the first evaluation following an induction BCG course.
Measured: Up to 5 years
Reasons for BCG Interruption
Number of participants with reasons for BCG interruption will be reported.
Measured: Up to 5 years
Therapy Choice at Recurrence
Therapy choice at recurrence for participants will be reported.
Measured: Up to 5 years
Recurrence-Free Survival (RFS)
RFS is defined as the time from the date of first treatment initiation for high-risk non-muscle invasive bladder cancer (HR-NMIBC) to the first documented recurrence of high-risk disease, death due to any cause, or censoring, whichever occurs first.
Measured: Up to 5 years
Progression-Free Survival (PFS)
PFS is defined as the time from the date of first treatment initiation for HR-NMIBC to the first documentation of disease progression, death from any cause, or censoring, whichever occurs first.
Measured: Up to 5 years
Overall Survival (OS)
OS is defined as the time from the date of first treatment initiation for HR-NMIBC to death from any cause or censoring, whichever occurs first.
Measured: Up to 5 years
Metastasis-Free Survival (MFS)
MFS is defined as the time from the date of first treatment initiation for HR-NMIBC to the occurrence of distant metastasis, death from any cause, or censoring, whichever occurs first.
Measured: Up to 5 years
Time to Next Treatment (TTNT)
TTNT is defined as the time from the date of first treatment initiation for HR-NMIBC to the initiation of the next line of treatment or censoring.
Measured: Up to 5 years
Time on Treatment (TOT)
TOT is defined as the duration between the first and last administration of the treatment.
Measured: Up to 5 years
Complete Response Rate (CR)
Complete response is defined as the absence of detectable bladder cancer at 6 months after completion of treatment, as confirmed by cystoscopic evaluation and optionally complemented by urine cytology.
Measured: Up to 5 years
Number and Type of Healthcare Resource Utilization Related to HR-NMIBC
Number and type of healthcare resource utilization related to HR-NMIBC, including procedures, hospitalizations and outpatient visits will be reported.
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2026
- Study start25 Aug 2026
- Primary completion15 Feb 2028 (estimated)
- Study completion25 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Bladder NeoplasmsStudies of the same condition, open and under way.
- 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
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Janssen-Cilag Farmaceutica Ltda.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen-Cilag Farmaceutica Ltda. Clinical Trial, Study director, Janssen-Cilag Farmaceutica Ltda.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07784387
- Sponsor's protocol ID
- 17000139BLC4007
- Acronym
- BRITE
- Status last verified
- Aug 2026
- First submitted
- 5 Aug 2026
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: The data sharing policy of Johnson \& Johnson Innovative Medicine is available at https://www.jnj.com/innovativemedicine/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu.
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-Risk Non-Muscle-Invasive Bladder Cancer (HR-NMIBC) Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT07784387
- Acronym / sponsor ID
- BRITE / 17000139BLC4007
- Conditions
- Urinary Bladder Neoplasms
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Janssen-Cilag Farmaceutica Ltda.Industry (pharma, biotech, devices)
- Study start
- 25 Aug 2026 (actual)
- Primary completion
- 15 Feb 2028 (estimated)
- Study completion
- 25 Feb 2028 (estimated)
- First posted
- 25 Aug 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.
The purpose of this study is to understand how the participants with high-risk non-muscle invasive bladder cancer are diagnosed, treated, and cared for in regular clinical practice in Portugal. HR-NMIBC is an early-stage bladder cancer that is limited to the inner lining of bladder but has a considerable high chance of cancer coming back or worsening.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HR-NMIBC Participants: Portuguese Routine Practice | – | –Participants diagnosed with high-risk non-muscle-Invasive bladder cancer (HR-NMIBC) in Portugal between January 1, 2016 and December 31, 2020, with tumor stage N0/x and M0/x and one of the following: Tis (primary CIS), TaG3/HG, or T1 will be enrolled. Demographic and clinical information will be gathered from both electronic and paper records for each participant. Only data available within routine clinical practice from the diagnosis until, at least, 5 years after diagnosis will be collected in this study. No drug will be administered as a part of this study. |
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 the participants from Portuguese hospitals that treat and manage High-Risk Non-Muscle Invasive Bladder Cancer (HR-NMIBC) in routine clinical practice.
Key inclusion criteria (3 listed)
- Bladder cancer diagnosis between January 1, 2016 and December 31, 2020
- Tumor stage N0/x and M0/x plus any of the following: Tis (primary CIS); TaG3/HG (high-grade non-invasive papillary carcinoma); or T1 (tumor invading subepithelial connective tissue)
- Minimal follow-up time of 5 years unless there is premature death event
Key exclusion criteria (3 listed)
- Tumor stage at diagnosis classified as TaG1-2, T2-T4, N1-3, or M1
- History of radical cystectomy performed either prior to the HR-NMIBC index diagnosis or for an indication unrelated to the index HR-NMIBC
- Participation in any interventional clinical trial during the observation period
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
Treatment Patterns: Type of Therapeutic Approach
Time frame: Up to 5 years
Number of participants receiving different types of therapeutic approach including bacillus calmette-guerin (BCG) therapy, chemotherapy, radiotherapy, immunotherapy, or targeted therapy will be reported.
Treatment Patterns: Type of Surgery
Time frame: Up to 5 years
Number of participants undergoing different types of surgery, including transurethral resection of the bladder tumor (TURBT), repeat TURBT or cystectomy will be reported.
Treatment Patterns by Subpopulation: Tumor Stage
Time frame: Up to 5 years
Number of participants by tumor stage will be reported.
Treatment Patterns by Subpopulation: Histology
Time frame: Up to 5 years
Number of participants by histology will be reported.
Treatment Patterns by Subpopulation: Line of Therapy
Time frame: Up to 5 years
Number of participants by line of therapy will be reported,
12 secondary outcomes
Total Number of BCG Doses Administered
Time frame: Up to 5 years
Percentage of Participants With BCG Non-Responsive Disease
Time frame: Up to 5 years
Reasons for BCG Interruption
Time frame: Up to 5 years
Therapy Choice at Recurrence
Time frame: Up to 5 years
Recurrence-Free Survival (RFS)
Time frame: Up to 5 years
Progression-Free Survival (PFS)
Time frame: Up to 5 years
Overall Survival (OS)
Time frame: Up to 5 years
Metastasis-Free Survival (MFS)
Time frame: Up to 5 years
Time to Next Treatment (TTNT)
Time frame: Up to 5 years
Time on Treatment (TOT)
Time frame: Up to 5 years
Complete Response Rate (CR)
Time frame: Up to 5 years
Number and Type of Healthcare Resource Utilization Related to HR-NMIBC
Time frame: Up to 5 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 28 Aug 2026.
- Individual participant dataSharing planned: Yes. The data sharing policy of Johnson \& Johnson Innovative Medicine is available at https://www.jnj.com/innovativemedicine/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu.
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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.
Janssen-Cilag Farmaceutica Ltda. Clinical Trial study director
Janssen-Cilag Farmaceutica Ltda.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Bladder Neoplasms, run by Janssen-Cilag Farmaceutica Ltda. at 1 site in Portugal.
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 3 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Study Contact (844-434-4210, Participate-In-This-Study1@its.jnj.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment Patterns: Type of Therapeutic Approach (time frame: Up to 5 years). The study lists 5 primary outcomes in all. 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 28 Aug 2026.