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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02039310

Enrollment

Registered

2014-01-17

Start date

2012-03-31

Completion date

2015-12-31

Last updated

2017-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bladder Cancer

Brief 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

65 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Impairment Free Survival	6 months	Impairment-free survival is defined as the time from radical cystectomy to the identification of: 1) major complication (Clavien score7 ≥ 3), 2) loss of independent living status, 3) ECOG performance status ≥ 3 beyond 4 weeks from RC, 4) global well-being or 5) death from any cause. Patients who drop-out before the 6-month end of study and who have not had an impairment event will be censored at their time of drop-out.

Countries

United States

Outcome results