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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

59 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-03-31

Study Completion Date

2015-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Bladder Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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≥ 65 years / opts for radical cystectomy

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No