Registry for patients with T1 urinary bladder cancer
Official title: Multicentric Prospective T1 Urinary Bladder Cancer (ROGUE-1) Registry
Run by Medical University of Vienna · NCT05792033 · Data updated 2026-11-12
This study is creating a registry for people with T1 urinary bladder cancer to help doctors better understand and manage their condition.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 90 Years |
| Sex | All |
| Enrollment | 700 (estimated) |
| Sponsor | Medical University of Vienna Academic / other |
| Locations | 1 site (Vienna) |
| Status | Recruiting |
| Started | June 1, 2021 |
| Main results expected | December 31, 2023 |
| Study ends | December 31, 2028 |
| Registry record updated | April 4, 2023 |
| Trial ID | NCT05792033 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include patients with a pathologically confirmed diagnosis of primary T1 bladder cancer who are eligible for surgery.
✕Probably not a fit
Patients with a history of bladder cancer, contraindications to surgery, or those with a life expectancy of less than one year may not benefit from this study.
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 aims to create a prospective registry for patients diagnosed with T1 urinary bladder cancer (UBC) to improve risk stratification and management. It addresses the challenges of accurate diagnosis and staging, which are often hindered by conventional tissue resection techniques. By collecting a clean dataset, the study seeks to enhance understanding of prognostic factors such as concomitant carcinoma in situ, variant histology, and lymphovascular invasion. The registry will facilitate better reporting and analysis of these features across different studies.
Why it matters
Potential benefit: If successful, this registry could lead to improved management and outcomes for patients with T1 urinary bladder cancer.
How similar studies have gone: While there have been studies on bladder cancer, this registry approach is novel in its focus on T1 UBC and the collection of a comprehensive dataset.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion criteria Subjects must meet all the following inclusion criteria to participate in this study: * Pathologically confirmed diagnosis of primary T1 bladder cancer * Diagnosis of primary T1 bladder cancer is confirmed at 2nd look TURB * Imaging examinations shows no lymph node metastasis or distant metastasis * Patients who agree to surgery, and will be effected to the standard postoperative management and follow-up treatment in accordance to current guidelines * In case of persistent T1 bladder cancer at 2nd look TURB, patient can be included only if detrusor muscle is present in the pathologic specimen Exclusion criteria * Previous bladder cancer * Upstaging to MIBC at 2nd look TURB * Contraindications to surgery (i.e. bladder fibrosis) * Poor performance status making a surgical intervention too risky * Life expectancy of less than one year * Patient refused to participate * Pregnancy * Concomitant or history of upper urinary tract urothelial cancer
Where it's running
-
Medical University of Vienna
Vienna, Austria Recruiting
Study contacts
- Study coordinator: David D'Andrea, MD
- Email: david.dandrea@meduniwien.ac.at
- Phone: +434040026150
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.