A Study to Characterize High-Risk Non-Muscle-Invasive Bladder Cancer Participants in Portugal (BRITE)

August 27, 2026 updated by: Janssen-Cilag Farmaceutica Ltda.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Portugal
      • Lisbon, Portugal, 1099-023
        • Recruiting
        • Ipo Lisboa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

Inclusion criteria:

  • 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

Exclusion criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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 the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Up to 5 years
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.
Up to 5 years
Treatment Patterns by Subpopulation: Tumor Stage
Time Frame: Up to 5 years
Number of participants by tumor stage will be reported.
Up to 5 years
Treatment Patterns by Subpopulation: Histology
Time Frame: Up to 5 years
Number of participants by histology will be reported.
Up to 5 years
Treatment Patterns by Subpopulation: Line of Therapy
Time Frame: Up to 5 years
Number of participants by line of therapy will be reported,
Up to 5 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Total Number of BCG Doses Administered
Time Frame: Up to 5 years
Total number of BCG doses administered will be reported.
Up to 5 years
Percentage of Participants With BCG Non-Responsive Disease
Time Frame: Up to 5 years
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.
Up to 5 years
Reasons for BCG Interruption
Time Frame: Up to 5 years
Number of participants with reasons for BCG interruption will be reported.
Up to 5 years
Therapy Choice at Recurrence
Time Frame: Up to 5 years
Therapy choice at recurrence for participants will be reported.
Up to 5 years
Recurrence-Free Survival (RFS)
Time Frame: Up to 5 years
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.
Up to 5 years
Progression-Free Survival (PFS)
Time Frame: Up to 5 years
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.
Up to 5 years
Overall Survival (OS)
Time Frame: Up to 5 years
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.
Up to 5 years
Metastasis-Free Survival (MFS)
Time Frame: Up to 5 years
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.
Up to 5 years
Time to Next Treatment (TTNT)
Time Frame: Up to 5 years
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.
Up to 5 years
Time on Treatment (TOT)
Time Frame: Up to 5 years
TOT is defined as the duration between the first and last administration of the treatment.
Up to 5 years
Complete Response Rate (CR)
Time Frame: Up to 5 years
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.
Up to 5 years
Number and Type of Healthcare Resource Utilization Related to HR-NMIBC
Time Frame: Up to 5 years
Number and type of healthcare resource utilization related to HR-NMIBC, including procedures, hospitalizations and outpatient visits will be reported.
Up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Janssen-Cilag Farmaceutica Ltda.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Janssen-Cilag Farmaceutica Ltda. Clinical Trial, Janssen-Cilag Farmaceutica Ltda.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 25, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 15, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 25, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 5, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 20, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 25, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 28, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 27, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 17000139BLC4007

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings