RESTORE-BLADDER (REgistry on STrategies for Organ pREservation in Muscle-invasive BLADDER Cancer)

NCT07744958 | Not Yet Recruiting

• 1 other identifier: 24072026
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Muscle Invasive Bladder Cancer (MIBC)

Keywords

Bladder Sparing; Muscle invasive bladder cancer; urothelial carcinoma

Outcome Measures

Primary Outcomes (1)

• 2 year MFS

  Metastatic free survival after two years

  2 Years

Interventions

None. Registry. OTHER

None. Registry.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient with muscle-invasive urothelial carcinoma of the bladder who decline to undergo radical cystectomy or radiotherapy after systemic therapy (perioperative attempt)

You may qualify if:

• 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

You may not qualify if:

• Age \< 18 years
• Lack of capacity to provide informed consent
• No histological confirmed muscle-invasive urothelial carcinoma
• No prior preoperative systemic therapy

Sponsors & Collaborators

• Heinrich-Heine University, Duesseldorf: lead

MeSH Terms

Conditions

Carcinoma, Transitional Cell

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Central Study Contacts

Camilla Grunewald, Dr. med.

CONTACT

00492118119353; camillamarisa.grunewald@med.uni-duesseldorf.de

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. med.

Study Record Dates

• First Submitted: July 30, 2026
• First Posted: August 4, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): February 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: August 4, 2026

Record last verified: 2026-07