Bladder Cancer Clinical Trial

Prediction of Impaired Survival in Elderly Bladder Cancer Patients Opting for Radical Cystectomy

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.

View Eligibility Criteria

Eligibility 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

Study is for people with:

Bladder Cancer

Estimated Enrollment:

59

Study ID:

NCT02039310

Recruitment Status:

Completed

Sponsor:

University of Michigan

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There is 1 Location for this study

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University of Michigan
Ann Arbor Michigan, 48109, United States

How clear is this clinincal trial information?

Study is for people with:

Bladder Cancer

Estimated Enrollment:

59

Study ID:

NCT02039310

Recruitment Status:

Completed

Sponsor:


University of Michigan

How clear is this clinincal trial information?

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