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 Type
OBSERVATIONAL
Enrollment
250
Ipo Lisboa
Lisbon, Portugal
RECRUITINGTreatment 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.
Time frame: 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.
Time frame: Up to 5 years
Treatment Patterns by Subpopulation: Tumor Stage
Number of participants by tumor stage will be reported.
Time frame: Up to 5 years
Treatment Patterns by Subpopulation: Histology
Number of participants by histology will be reported.
Time frame: Up to 5 years
Treatment Patterns by Subpopulation: Line of Therapy
Number of participants by line of therapy will be reported,
Time frame: Up to 5 years
Total Number of BCG Doses Administered
Total number of BCG doses administered will be reported.
Time frame: 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.
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Time frame: Up to 5 years
Reasons for BCG Interruption
Number of participants with reasons for BCG interruption will be reported.
Time frame: Up to 5 years
Therapy Choice at Recurrence
Therapy choice at recurrence for participants will be reported.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 5 years
Time on Treatment (TOT)
TOT is defined as the duration between the first and last administration of the treatment.
Time frame: 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.
Time frame: 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.
Time frame: Up to 5 years