Perioperative Systemic Therapies in Muscle-Invasive Bladder Cancer (GUARDIANS)
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Wiek co najmniej 18 lat.
- •Rak pęcherza potwierdzony w badaniu histopatologicznym, który nacieka mięśnie lub jest zaawansowany miejscowo.
- •Pacjent ma zaplanowane, otrzymuje lub zakończył leczenie systemowe przed lub po operacji (różne rodzaje leczenia, np. Enfortumab Vedotin z Pembrolizumabem, Gemcytabina/Cisplatyna/Durwalumab, lub inne standardowe podejścia).
- •Pacjentowi zaplanowano lub wykonano usunięcie pęcherza jako część leczenia mającego na celu wyleczenie.
- •Pacjent wyraził pisemną zgodę na zbieranie danych (jeśli wymagane dla nowego zbierania danych).
✗ Disqualifies
- •Brak wymaganej zgody pacjenta na zbieranie nowych danych.
- •Zbyt mało informacji o pacjencie lub leczeniu, aby można było ocenić jego stan.
- •Pacjent nie otrzymuje leczenia systemowego przed lub po operacji, lub nie można go zakwalifikować do badanej grupy.
- •Brak danych z wizyt kontrolnych lub niejasne dokumenty uniemożliwiające ocenę wyników.
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- October 2, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (1)
Department of Urology, LMU University Hospital Munich
Munich, Germany
Trial contact
Can Aydogdu, MD
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 10/3/2026.
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