This trial is active, not recruiting.

Condition bladder cancer
Sponsor University of Michigan
Start date March 2012
End date June 2017
Trial size 50 participants
Trial identifier NCT02039310, HUM00057382


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

Impairment Free Survival
time frame: 6 months

Eligibility Criteria

Male or female participants at least 65 years old.

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

Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by University of Michigan.