RESTORE-BLADDER (REgistry on STrategies for Organ pREservation in Muscle-invasive BLADDER Cancer)
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHeinrich-Heine University, Duesseldorf
About this trial
Removal of the urinary bladder (radical cystectomy) is a major surgical procedure that can have a permanent impact on a patient's quality of life. Consequently, some patients, despite having received comprehensive counseling and completing systemic therapy, decide against subsequent surgery or alternative radiotherapy. Recent scientific studies suggest that, for selected patients, an attempt at bladder preservation may be a medically justifiable option. However, it remains unclear which patients are truly suitable candidates for bladder-preserving management and which are not. The aim of this registry is therefore to collect and analyze clinical data from this specific patient population.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients aged >= 18 years, capable of providing informed consent
Histologically confirmed muscle-invasive urothelial carcinoma of the urinary bladder
Received perioperative systemic therapy in accordance with current guidelines and subsequently decline cystectomy or radiotherapy
Disqualifiers
Age < 18 years
Lack of capacity to provide informed consent
No histological confirmed muscle-invasive urothelial carcinoma
No prior preoperative systemic therapy
Trial population
Patient with muscle-invasive urothelial carcinoma of the bladder who decline to undergo radical cystectomy or radiotherapy after systemic therapy (perioperative attempt)
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
None. Registry.
Other interventionNone. Registry.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
2 year MFS
Metastatic free survival after two years
Time frame
2 YearsLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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