Urinary Bladder Neoplasms
Conditions
Brief 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. 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.
Interventions
None listed
Sponsors
Janssen-Cilag Farmaceutica Ltda.
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Patterns: Type of Therapeutic Approach | 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 | 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 | Up to 5 years | Number of participants by tumor stage will be reported. |
| Treatment Patterns by Subpopulation: Histology | Up to 5 years | Number of participants by histology will be reported. |
| Treatment Patterns by Subpopulation: Line of Therapy | Up to 5 years | Number of participants by line of therapy will be reported, |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Number of BCG Doses Administered | Up to 5 years | Total number of BCG doses administered will be reported. |
| Percentage of Participants With BCG Non-Responsive Disease | 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. |
| Reasons for BCG Interruption | Up to 5 years | Number of participants with reasons for BCG interruption will be reported. |
| Therapy Choice at Recurrence | Up to 5 years | Therapy choice at recurrence for participants will be reported. |
| Recurrence-Free Survival (RFS) | 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. |
| Progression-Free Survival (PFS) | 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. |
| Overall Survival (OS) | 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. |
| Metastasis-Free Survival (MFS) | 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. |
| Time to Next Treatment (TTNT) | 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. |
| Time on Treatment (TOT) | Up to 5 years | TOT is defined as the duration between the first and last administration of the treatment. |
| Complete Response Rate (CR) | 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. |
| Number and Type of Healthcare Resource Utilization Related to HR-NMIBC | Up to 5 years | Number and type of healthcare resource utilization related to HR-NMIBC, including procedures, hospitalizations and outpatient visits will be reported. |
Countries
Portugal
Contacts
CONTACTStudy Contact
STUDY_DIRECTORJanssen-Cilag Farmaceutica Ltda. Clinical Trial
Janssen-Cilag Farmaceutica Ltda.
Outcome results
None listed