RECRUITINGOBSERVATIONAL
A Study to Assess Real-World Use and Outcomes of TAR-200 for Participants With Non-Muscle Invasive Bladder Cancer (NMIBC) in the United States
A Multicenter, Prospective, Longitudinal Study to Assess Real-World Use and Outcomes After the Launch of TAR-200 for NMIBC in the US
About This Trial
The purpose of this study is to assess how well TAR-200 works in real-word by measuring the time taken from the first TAR-200 insertion to worsening of cancer or until the signs and symptoms of cancer occur again (disease-free survival) in participants with non-muscle invasive bladder cancer (NMIBC; an early-stage bladder cancer that is limited to the inner lining of bladder).
Who May Be Eligible (Plain English)
Who May Qualify:
- Has a confirmed diagnosis of NMIBC based on TURBT or cold cup biopsy
- Initiated first dose of TAR-200 in a real-world setting within 6 weeks prior to baseline visit/Study visit 1
- Participants with childbearing potential are required to adhere to contraceptive recommendations as specified in the approved product labeling for TAR-200. Additionally, participants should seek consultation with their physician for personalized contraceptive advice
- Must provide willing to sign a consent form as described in the protocol
Who Should NOT Join This Trial:
- Has any medical condition deemed by the health care practitioner (HCP) as contraindicated to receive TAR-200 treatment
- Had previous treatment with TAR-200 discontinued prior to baseline visit/Study visit 1
- Previously received TAR-200 intravesically as part of a clinical trial(s)
- Previously received greater than (\>) 2 doses/cycles of TAR-200 in the real-world setting
- Currently participating in an interventional bladder cancer clinical trial
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
Inclusion criteria:
* Has a confirmed diagnosis of NMIBC based on TURBT or cold cup biopsy
* Initiated first dose of TAR-200 in a real-world setting within 6 weeks prior to baseline visit/Study visit 1
* Participants with childbearing potential are required to adhere to contraceptive recommendations as specified in the approved product labeling for TAR-200. Additionally, participants should seek consultation with their physician for personalized contraceptive advice
* Must provide informed consent as described in the protocol
Exclusion criteria:
* Has any medical condition deemed by the health care practitioner (HCP) as contraindicated to receive TAR-200 treatment
* Had previous treatment with TAR-200 discontinued prior to baseline visit/Study visit 1
* Previously received TAR-200 intravesically as part of a clinical trial(s)
* Previously received greater than (\>) 2 doses/cycles of TAR-200 in the real-world setting
* Currently participating in an interventional bladder cancer clinical trial
Locations (1)
Arkansas Urology
Little Rock, Arkansas, United States