Urothelial Carcinoma of the BladderGUARDIANSNCT07855926
Perioperative Systemic Therapies in Muscle-Invasive Bladder Cancer (GUARDIANS)
An observational study of Urothelial Carcinoma of the Bladder and Muscle Invasive Bladder Cancer (MIBC), run by LMU Klinikum at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urothelial Carcinoma of the Bladder, Muscle Invasive Bladder Cancer (MIBC)
- What is being tested?
- Perioperative Systemic Therapy Registry
- How many people
- 500 participants
- Where
- 1 siteGermany
- Study dates
- 17 May 2026to 31 May 2029
- How long will I take part?
- 36 Months
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with muscle-invasive or locally advanced urothelial carcinoma of the bladder receiving perioperative systemic therapy in routine clinical practice. Patients are treated in the neoadjuvant and/or adjuvant setting with curative intent and undergo or are planned for radical cystectomy with pelvic lymph node dissection. Treatment approaches include Enfortumab Vedotin plus Pembrolizumab, Gemcitabine/Cisplatin/Durvalumab, cisplatin-based chemotherapy, immunotherapy, and other standard perioperative systemic therapies. Both prospective and retrospective patients from participating GUARDIANS centers are included.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Department of Urology, LMU University Hospital Munich
Munich, 81377
Can Aydogdu, MD, +49 89 4400 0, can.aydogdu@med.uni-muenchen.de
About this study
Official title: 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.
Read the detailed description
The GUARDIANS perioperative registry is a multicenter observational study designed to collect real-world data on perioperative systemic therapies in patients with muscle-invasive or locally advanced urothelial carcinoma of the bladder.
Perioperative systemic treatment strategies for muscle-invasive bladder cancer are rapidly evolving and include antibody-drug conjugate-based combinations such as Enfortumab Vedotin plus Pembrolizumab as well as cisplatin-based regimens including Gemcitabine/Cisplatin/Durvalumab and other standard neoadjuvant and adjuvant treatment approaches. While these regimens are increasingly used in routine care, systematic real-world evidence regarding feasibility, dose intensity, perioperative safety, patient-reported neurotoxicity, pathologic response, and long-term oncologic outcomes remains limited.
This registry evaluates perioperative treatment strategies with particular focus on real-world implementation, treatment completion, and comparative outcomes across different systemic therapy approaches. Patients are followed longitudinally from baseline and diagnosis through neoadjuvant therapy, radical cystectomy with pelvic lymph node dissection, adjuvant therapy when applicable, and long-term follow-up.
The primary objective is evaluation of event-free survival (EFS) and treatment feasibility. Feasibility includes completion of intended radical cystectomy, delivery of planned neoadjuvant and adjuvant treatment components, and reasons for treatment delay, modification, or discontinuation.
Secondary objectives include assessment of:
Pathologic complete response (pCR, ypT0N0) Pathologic downstaging Disease-free survival (DFS) Overall survival (OS) Local and distant recurrence patterns 90-day postoperative complications after radical cystectomy CTCAE version 5.0 treatment-related toxicities Patient-reported chemotherapy-induced peripheral neuropathy symptoms Treatment exposure and dose intensity The study is non-interventional. All diagnostic and therapeutic decisions are made independently of study participation according to local standard of care. No additional mandatory visits, diagnostic procedures, or therapeutic interventions are required.
Data are collected pseudonymized using REDCap across participating GUARDIANS centers. Prospective collection includes patient-reported outcome measures for neurotoxicity, while retrospective collection allows inclusion of previously treated patients according to ethics approval and local regulations. The registry supports evaluation of real-world outcomes across multiple perioperative treatment strategies and provides comparative evidence for routine clinical practice.
- Being tested
- Perioperative Systemic Therapy Registry
- Keywords
- Perioperative Systemic Therapy, Muscle-Invasive Bladder Cancer, Urothelial Carcinoma, Enfortumab Vedotin, Pembrolizumab, Gemcitabine, Cisplatin, Durvalumab, Radical Cystectomy, Neoadjuvant Therapy, Adjuvant Therapy, Real-World Data, Patient Registry, GUARDIANS, CIPN, Pathologic Complete Response, Event-Free Survival
- Medical subject headings
- Carcinoma, Transitional Cell, Pathologic Complete Response
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perioperative Systemic Therapy RegistryOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Event Free Survival (EFS)
Measured: From treatment initiation up to 36 months
Secondary outcomes (8)
Pathologic Complete Response (pCR)
Measured: At radical cystectomy
Pathologic Downstaging
Defined as less than ypT2N0 in the cystectomy specimen, including pT0, pTis, pTa, and pT1.
Measured: At radical cystectomy
Disease-Free Survival (DFS)
Time from curative surgery until recurrence or death.
Measured: Up to 36 months after surgery
Overall Survival (OS)
Time from treatment initiation until death from any cause.
Measured: Up to 60 months
Change Over Time in Patient-Reported Peripheral Neuropathy Assessed by the EORTC QLQ-CIPN20
Patient-reported peripheral neuropathy symptoms will be assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Chemotherapy-Induced Peripheral Neuropathy 20 (EORTC QLQ-CIPN20). The questionnaire assesses sensory, motor, and autonomic symptoms of peripheral neuropathy. Subscale scores are calculated according to the EORTC scoring procedure and linearly transformed to a scale ranging from 0 to 100. Higher scores indicate greater peripheral neuropathy symptom burden and therefore a worse outcome. Changes from baseline will be assessed longitudinally during perioperative treatment through end of treatment.
Measured: Baseline; within 14 days before radical cystectomy; start of adjuvant therapy ±14 days; weeks 12, 21, and 30 of adjuvant therapy ±14 days; and end of treatment ±14 days
Treatment-Related Adverse Events
Occurrence, type, severity, attribution, management, and outcome of treatment-related adverse events associated with perioperative enfortumab vedotin and pembrolizumab. Adverse event severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 5.0.
Measured: From first administration of neoadjuvant therapy through the end-of-treatment visit, up to approximately 12 months
90-Day Postoperative Complications
Occurrence and severity of postoperative complications within 90 days after radical cystectomy, graded according to the Clavien-Dindo classification.
Measured: Up to 90 days after radical cystectomy
90-Day Perioperative Mortality
All-cause mortality occurring within 90 days after radical cystectomy following perioperative systemic therapy. This includes deaths related to surgical complications, treatment-related toxicity, or other causes during the perioperative period.
Measured: Up to 90 days after radical cystectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2026
- Study start17 May 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urothelial Carcinoma of the BladderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 36 Months
Sponsor and investigators
- Lead sponsor
- LMU Klinikum
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Can Aydogdu, MD, LMU Klinikum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07855926
- Sponsor's protocol ID
- GUARDIANS
- Acronym
- GUARDIANS
- Status last verified
- May 2026
- First submitted
- 17 May 2026
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided