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NCT Number: NCT07784387

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ipo Lisboa

Lisbon, 1099-023, Portugal

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

  3. Treatment Patterns by Subpopulation: Tumor Stage

    Time frame: Up to 5 years

    Number of participants by tumor stage will be reported.

  4. Treatment Patterns by Subpopulation: Histology

    Time frame: Up to 5 years

    Number of participants by histology will be reported.

  5. Treatment Patterns by Subpopulation: Line of Therapy

    Time frame: Up to 5 years

    Number of participants by line of therapy will be reported,

Secondary outcomes

  1. Total Number of BCG Doses Administered

    Time frame: Up to 5 years

    Total number of BCG doses administered will be reported.

  2. 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.

  3. Reasons for BCG Interruption

    Time frame: Up to 5 years

    Number of participants with reasons for BCG interruption will be reported.

  4. Therapy Choice at Recurrence

    Time frame: Up to 5 years

    Therapy choice at recurrence for participants will be reported.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Study Contact

CONTACT

[email protected]

844-434-4210

Sponsors and collaborators

Lead sponsor

Janssen-Cilag Farmaceutica Ltda.

Industry

Registry information

Official study title

High-Risk Non-Muscle-Invasive Bladder Cancer (HR-NMIBC) Retrospective Cohort Study

Acronym: BRITE

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Aug 25, 2026
Registry last updated
Aug 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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