Prediction of Impaired Survival in Elderly Bladder Cancer Patients Opting for Radical Cystectomy
Conditions
Bladder Cancer
Conditions: official terms
Urinary Bladder Neoplasms
Study Type
Observational
Study Phase
N/A
Study Design
Observational Model: Cohort, Time Perspective: Prospective
Overall Status
Recruiting
Summary
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 65 Years
Gender: Both
Criteria: 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
Location
University of Michigan
Ann Arbor, Michigan, United States
Status: Recruiting
Contact: Cheryl T Lee, MD - 734-615-6662 - ctlee@med.umich.edu
Start Date
March 2012
Sponsors
University of Michigan
Source
University of Michigan
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page