Ipo Lisboa
Lisbon, 1099-023, Portugal
Location status: Recruiting
NCT Number: NCT07784387
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Lisbon, 1099-023, Portugal
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: Up to 5 years
Number of participants by tumor stage will be reported.
Time frame: Up to 5 years
Number of participants by histology will be reported.
Time frame: Up to 5 years
Number of participants by line of therapy will be reported,
Time frame: Up to 5 years
Total number of BCG doses administered will be reported.
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.
Time frame: Up to 5 years
Number of participants with reasons for BCG interruption will be reported.
Time frame: Up to 5 years
Therapy choice at recurrence for participants will be reported.
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.
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.
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.
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.
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.
Time frame: Up to 5 years
TOT is defined as the duration between the first and last administration of the treatment.
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.
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.
Contact information is provided by the study sponsor or research team.
Janssen-Cilag Farmaceutica Ltda.
Industry
High-Risk Non-Muscle-Invasive Bladder Cancer (HR-NMIBC) Retrospective Cohort Study
Acronym: BRITE
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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