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Clinical Trials in Germany / NCT07855926
Recruiting Observational

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

NCT07855926 · tracked via the Priya Life Science Germany tracker
Sponsor
LMU Klinikum
Phase
Observational
Started
2026-05-17
Last updated
2026-10-02

Condition(s) studied

Urothelial Carcinoma of the BladderMuscle Invasive Bladder Cancer (MIBC)

Investigational drug(s) / intervention(s)

Perioperative Systemic Therapy Registry

Perioperative Systemic Therapy Registry: Observational registry of patients with muscle-invasive bladder cancer receiving perioperative systemic therapy as part of routine clinical care. Treatments are not assigned by protocol and may include Enfortumab Vedotin plus Pembrolizumab, Gemcitabine/Cisplatin/Durvalumab, cisplatin-based chemotherapy, immunotherapy, and other standard neoadjuvant or adjuvant treatment approaches. All therapeutic decisions are made independently by treating physicians according to local standard of care.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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 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

Primary outcome measure(s)

  • Event Free Survival (EFS) — From treatment initiation up to 36 months

Trial sites (1)

FacilityCityRegionStatus
Department of Urology, LMU University Hospital Munich Munich Germany Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07855926 on ClinicalTrials.gov ↗ ← All trials in Germany