NCT07309445Recruiting
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
Source: ClinicalTrials.gov · Last updated 3 Nov 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 150 (estimated)
- First submitted
- 16 Dec 2025
- Start date
- 12 Jun 2026
- Primary completion date
- 31 Mar 2029
- Lead sponsor
- Janssen Research & Development, LLC
- Diseases
- Bladder cancer
- NCT number
- NCT07309445
What you commit to
- Study type: Observational
- Planned participants: 150
- From 12 Jun 2026 to the primary completion date, 31 Mar 2029
- 23 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior 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
Other illness
- Has any medical condition deemed by the health care practitioner (HCP) as contraindicated to receive TAR-200 treatment
- Currently participating in an interventional bladder cancer clinical trial
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (23)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UPNT Research Institute Coordinator of this site? Confirm its status | Arlington | United States | Recruiting |
| University of Alabama at Birmingham Coordinator of this site? Confirm its status | Birmingham | United States | Recruiting |
| MidLantic Urology - Haverford Road - Bryn Mawr Coordinator of this site? Confirm its status | Bryn Mawr | United States | Recruiting |
| Urology Specialists of the Carolinas PLLC Charlotte Coordinator of this site? Confirm its status | Charlotte | United States | Recruiting |
| Associated Urological Specialists Coordinator of this site? Confirm its status | Chicago Ridge | United States | Recruiting |
| UT Southwestern Medical Center Coordinator of this site? Confirm its status | Dallas | United States | Recruiting |
| Frederick Health Coordinator of this site? Confirm its status | Frederick | United States | Recruiting |
| Indiana University/Melvin and Bren Simon Cancer Center Coordinator of this site? Confirm its status | Indianapolis | United States | Recruiting |
| Mayo Clinic Coordinator of this site? Confirm its status | Jacksonville | United States | Recruiting |
| Colorado Clinical Research Coordinator of this site? Confirm its status | Lakewood | United States | Recruiting |
| Arkansas Urology Coordinator of this site? Confirm its status | Little Rock | United States | Recruiting |
| USC / Norris Comprehensive Cancer Center Coordinator of this site? Confirm its status | Los Angeles | United States | Recruiting |
| Cedars-Sinai Medical Center Coordinator of this site? Confirm its status | Los Angeles | United States | Recruiting |
| Low Country Urology Clinics Coordinator of this site? Confirm its status | North Charleston | United States | Recruiting |
| Mayo Clinic 1 Coordinator of this site? Confirm its status | Phoenix | United States | Recruiting |
| Mayo Clinic - Rochester Coordinator of this site? Confirm its status | Rochester | United States | Recruiting |
| University of Washington School of Medicine Coordinator of this site? Confirm its status | Seattle | United States | Recruiting |
| Urology Specialists of South Dakota Coordinator of this site? Confirm its status | Sioux Falls | United States | Recruiting |
| Spokane Urology Coordinator of this site? Confirm its status | Spokane | United States | Recruiting |
| Specialty Clinical Research of St. Louis Coordinator of this site? Confirm its status | St Louis | United States | Recruiting |
| SUNY Upstate Med Univ Coordinator of this site? Confirm its status | Syracuse | United States | Recruiting |
| Michigan Institute of Urology Coordinator of this site? Confirm its status | Troy | United States | Recruiting |
| Florida Urology Partners Coordinator of this site? Confirm its status | Wimauma | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.