Prediction of Impaired Survival in Elderly Bladder Cancer Patients Opting for Radical Cystectomy
| Status: | Recruiting |
|---|---|
| Conditions: | Cancer, Cancer, Bladder Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 65 - Any |
| Updated: | 4/2/2016 |
| Start Date: | March 2012 |
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.
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.
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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