NON-MUSCLE INVASIVE BLADDER CANCER C67
Conditions
Interventions
Group 1: - Sub-Cohort A – with carcinoma in situ (CIS) at baseline (CIS only orTa+CIS, T1+CIS)
- Sub-Cohort B – without CIS at baseline (High Grade Ta or Any Grade T1)
In both cohorts the patient data will be retrospectively collected from the date of enrollment in the study till the 31. Dec. 2018 or the death of the patient, in accordance what occurs first.
Sponsors
Merck Sharp & Dohme Corp.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: histologically-confirmed diagnosis of high risk non-muscle-invasive (T1 [any grade], high grade Ta and / or carcinoma in situ [CIS]) transitional cell carcinoma of the bladder (mixed histology tumors allowed if transitional cell histology is predominant histology)
Exclusion criteria
Exclusion criteria: Muscle-invasive, locally advanced nonresectable, or metastatic urothelialcarcinoma (i.e., T2, T3, T4, and / or stage IV) at index date
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Collected will be data for the period 2011-2018 real-world NMIBC (non-muscle invasive bladder cancer). The primary outcomes will include real-world complete response rate and real-world disease-free survival. These outcomes will be assessed using high quality real world data as per urine cytology, cystoscopy, and/or biopsy and imaging (CTU) and associated clinical data. | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival, real-world time to cystectomy. | — |
Countries
Canada, France, Germany, Netherlands, South Korea, United States
Contacts
Public ContactMehmet Burcu
Merck Sharp&Dohme GmbH
Outcome results
None listed