Real-world follow-up of drug treatment around surgery for muscle-invasive bladder cancer
Follows adults with muscle-invasive bladder cancer who receive drug treatment around surgery.
Plain-language title generated from the registry record
Registry title: Perioperative Systemic Therapies in Muscle-Invasive Bladder Cancer (GUARDIANS)
Key facts
- Where
- Munich, GermanySee the site
Where in Germany
- Department of Urology, LMU University Hospital MunichMunich, GermanyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- LMU Klinikum
- Trial code
- NCT07855926
- Record updated
- 2 October 2026
- Original description
This is a multicenter, non-interventional, prospective and retrospective observational patient registry study of adults with muscle-invasive bladder cancer receiving perioperative systemic therapy as part of routine clinical care. The registry includes patients treated with perioperative systemic therapies such as Enfortumab Vedotin plus Pembrolizumab as well as cisplatin-based combinations including Gemcitabine/Cisplatin/Durvalumab and other standard perioperative treatment approaches in the neoadjuvant and adjuvant setting.Read full original descriptionShow less
Perioperative GUARDIANS Project: Real-World Evaluation of Feasibility, Toxicity, and Oncologic Outcomes of Perioperative Systemic Therapies in Muscle-Invasive Urothelial Carcinoma
This is a multicenter, non-interventional, prospective and retrospective observational patient registry study of adults with muscle-invasive bladder cancer receiving perioperative systemic therapy as part of routine clinical care. The registry includes patients treated with perioperative systemic therapies such as Enfortumab Vedotin plus Pembrolizumab as well as cisplatin-based combinations including Gemcitabine/Cisplatin/Durvalumab and other standard perioperative treatment approaches in the neoadjuvant and adjuvant setting.
The study aims to evaluate real-world feasibility, treatment tolerability, pathologic response, and oncologic outcomes of perioperative systemic treatment strategies. Key outcomes include event-free survival (EFS), pathologic complete response (pCR), pathologic downstaging, disease-free survival (DFS), overall survival (OS), perioperative complications, and treatment-related adverse events. Patient-reported neurotoxicity symptoms will also be assessed using standardized neuropathy questionnaires.
All treatments, surgeries, and follow-up procedures are performed according to routine clinical practice. No study-specific interventions are assigned. Clinical data are collected pseudonymized through participating GUARDIANS centers using standardized electronic case report forms. Both prospective and retrospective data collection are included.
Inclusion: Age ≥18 years; Histologically confirmed muscle-invasive or locally advanced urothelial carcinoma of the bladder; Planned, ongoing, or completed perioperative systemic therapy, including but not limited to Enfortumab Vedotin plus Pembrolizumab, Gemcitabine/Cisplatin/Durvalumab, cisplatin-based chemotherapy, immunotherapy, or other standard perioperative treatment approaches; Radical cystectomy planned or performed as part of curative-intent treatment strategy; Written informed consent for prospective data collection, where required; Sufficient clinical documentation available for retrospective inclusion, including at least one follow-up assessment.
Exclusion: No perioperative systemic therapy or inability to assign patient to a study cohort; Missing informed consent where prospectively required; Insufficient documentation of key baseline data or treatment exposure; Follow-up data unavailable or inconsistent documentation preventing endpoint assessment.