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Not Yet Recruiting

NCT Number: NCT07744958

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

None. Registry.

Other

None. Registry.

Primary outcomes

  1. 2 year MFS

    Time frame: 2 Years

    Metastatic free survival after two years

Study contacts

Contact information is provided by the study sponsor or research team.

Camilla Grunewald, Dr. med.

CONTACT

[email protected]

00492118119353

Sponsors and collaborators

Lead sponsor

Heinrich-Heine University, Duesseldorf

Other

Registry information

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Aug 4, 2026
Registry last updated
Aug 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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