NCT07855926Recruiting
Perioperative Systemic Therapies in Muscle-Invasive Bladder Cancer (GUARDIANS)
Perioperative GUARDIANS Project: Real-World Evaluation of Feasibility, Toxicity, and Oncologic Outcomes of Perioperative Systemic Therapies in Muscle-Invasive Urothelial Carcinoma
Source: ClinicalTrials.gov · Last updated 2 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 500 (estimated)
- First submitted
- 17 May 2026
- Start date
- 17 May 2026
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- LMU Klinikum
- Diseases
- Bladder cancer
- NCT number
- NCT07855926
What you commit to
- Study type: Observational
- Planned participants: 500
- From 17 May 2026 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- No perioperative systemic therapy or inability to assign patient to a study cohort
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Urology, LMU University Hospital Munich Coordinator of this site? Confirm its status | Munich | Germany | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.