Clinical trial · Observational
Prediction of Impaired Survival in Elderly Bladder Cancer Patients Opting for Radical Cystectomy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The investigators proposes a prospective cohort study in patients with high risk bladder cancer who have opted for radical cystectomy. The investigators aim to correlate pre-operative measures of body composition, cognitive and functional status with impaired survival at 6 months after cystectomy. Impairment in this context will be a compilation of several specific objective measures including: 1) death from any cause, 2) major complication (Clavien score7 ≥ 3), 3) loss of independent living status, 4) performance status, and 5) global well-being. The study team believes that Impairment Free Survival is an important endpoint as it accounts for many aspects of a patient's functional status that might alter a patient's choice to proceed with radical surgery.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- ≥ 65 years / opts for radical cystectomy
Primary outcomes (1)
- measure
- Impairment Free Survival
- timeFrame
- 6 months
- description
- Impairment-free survival is defined as the time from radical cystectomy to the identification of: 1) major complication (Clavien score7 ≥ 3), 2) loss of independent living status, 3) ECOG performance status ≥ 3 beyond 4 weeks from RC, 4) global well-being or 5) death from any cause. Patients who drop-out before the 6-month end of study and who have not had an impairment event will be censored at their time of drop-out.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Histologic diagnosis of bladder carcinoma (any histology permitted) * Planned treatment with radical cystectomy. * Age 65 years or older at the time of radical cystectomy * Able to give consent * Neoadjuvant chemotherapy is permissible * Prior malignancy is permissible, without evidence of disease for at least 2 years * Concomitant localized prostate cancer, skin cancer, and in situ malignancies are permissible. * Willingness to complete surgical follow-up at the University of Michigan for at least 6 months after radical cystectomy. Exclusion Criteria: * Evidence of metastatic bladder cancer * Life expectancy less than one year * Concurrent treatment on another clinical trial. Non-intervention supportive care trials or non-treatment trials, e.g. QOL, are allowed
References
Publications (0)
Data not yet available