Prediction of Impaired Survival in Elderly Bladder Cancer Patients Opting for Radical Cystectomy
This trial is active, not recruiting.
|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.
Impairment Free Survival
time frame: 6 months
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
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