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

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: Recruiting
• Conditions: Urinary Bladder Neoplasms

• Study Type: Observational
• Enrollment (Estimated): 250

Contacts and Locations

• Study Contact: Name: Study Contact; Phone Number: 844-434-4210; Email: Participate-In-This-Study1@its.jnj.com

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

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

Outcome Measure	Measure Description	Time Frame
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.	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.	Up to 5 years
Treatment Patterns by Subpopulation: Tumor Stage	Number of participants by tumor stage will be reported.	Up to 5 years
Treatment Patterns by Subpopulation: Histology	Number of participants by histology will be reported.	Up to 5 years
Treatment Patterns by Subpopulation: Line of Therapy	Number of participants by line of therapy will be reported,	Up to 5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Number of BCG Doses Administered	Total number of BCG doses administered will be reported.	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.	Up to 5 years
Reasons for BCG Interruption	Number of participants with reasons for BCG interruption will be reported.	Up to 5 years
Therapy Choice at Recurrence	Therapy choice at recurrence for participants will be reported.	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.	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.	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.	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.	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.	Up to 5 years
Time on Treatment (TOT)	TOT is defined as the duration between the first and last administration of the treatment.	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.	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.	Up to 5 years

Collaborators and Investigators

• Sponsor: Janssen-Cilag Farmaceutica Ltda.
• Investigators: Study Director: Janssen-Cilag Farmaceutica Ltda. Clinical Trial, Janssen-Cilag Farmaceutica Ltda.

Study record dates

Study Major Dates

• Study Start (Actual): August 25, 2026
• Primary Completion (Estimated): February 15, 2028
• Study Completion (Estimated): February 25, 2028

Study Registration Dates

• First Submitted: August 5, 2026
• First Submitted That Met QC Criteria: August 20, 2026
• First Posted (Actual): August 25, 2026

Study Record Updates

• Last Update Posted (Actual): August 28, 2026
• Last Update Submitted That Met QC Criteria: August 27, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urologic Neoplasms; Urinary Bladder Diseases; Urinary Bladder Neoplasms
• Other Study ID 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.