Understanding how high-risk non-muscle-invasive bladder cancer is diagnosed and cared for in Portugal

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study analyzes real-world clinical practice for patients with high-risk non-muscle-invasive bladder cancer in Portugal. It includes patients diagnosed between 2016 and 2020 and requires at least five years of follow-up, unless death occurs earlier. The goal is to describe diagnostic pathways, treatment patterns, and care practices in routine settings. No interventional procedures are involved, and patients who had invasive disease at diagnosis or prior cystectomy are excluded. The lead sponsor is Janssen-Cilag Farmaceutica Ltda., with ongoing data collection at Ipo Lisboa in Lisbon.

Why it matters

Who can join: the full rules

Inclusion criteria:

* Bladder cancer diagnosis between January 1, 2016 and December 31, 2020
* Tumor stage N0/x and M0/x plus any of the following: Tis (primary CIS); TaG3/HG (high-grade non-invasive papillary carcinoma); or T1 (tumor invading subepithelial connective tissue)
* Minimal follow-up time of 5 years unless there is premature death event

Exclusion criteria:

* Tumor stage at diagnosis classified as TaG1-2, T2-T4, N1-3, or M1
* History of radical cystectomy performed either prior to the HR-NMIBC index diagnosis or for an indication unrelated to the index HR-NMIBC
* Participation in any interventional clinical trial during the observation period

Where it's running

• Ipo Lisboa
  Lisbon, Portugal Recruiting

Study contacts

• Study coordinator: Study Contact
• Email: Participate-In-This-Study1@its.jnj.com
• Phone: 844-434-4210

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.