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Perioperative Systemic Therapies in Muscle-Invasive Bladder Cancer (GUARDIANS)

Recruitingn/aAges 18 Years - anyAllLMU Klinikum
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In plain words

What the trial is, and whether it could suit you

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 treatme

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Age โ‰ฅ18 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 Criteria: * Missing informed consent where prospectively required * Insufficient documentation of key baseline data or treatment exposure * No perioperative systemic therapy or inability to assign patient to a study cohort * Follow-up data unavailable or inconsistent documentation preventing endpoint assessment
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What it tests

  • Perioperative Systemic Therapy Registry
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Where

1 site
Department of Urology, LMU University Hospital Munich
Munich, Germany
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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