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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

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

ArmDescriptionAssigned 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

More Details

Status
Recruiting
Sponsor
Janssen Research & Development, LLC

Study Contact

Study Contact
844-434-4210
Participate-In-This-Study1@its.jnj.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.