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
Purpose
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).
Condition
- Non-Muscle Invasive Bladder Neoplasms
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| NMIBC Participants: Routine Clinical Practice Setting | Participants with confirmed diagnosis of NMIBC and who have initiated first dose of TAR-200 in a real-world clinical setting, within 6 weeks prior to baseline visit/Study visit 1 will be observed for 24 months from the initiation of the first dose of TAR-200, or until the participant dies, is lost to follow-up, or withdraws consent in the study. No intervention will be administered as a part of this study. |
Recruiting Locations
Arkansas Urology
Little Rock, Arkansas 72211
Little Rock, Arkansas 72211
More Details
- Status
- Recruiting
- Sponsor
- Janssen Research & Development, LLC