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

University of Michigan

Status: Completed

Conditions: Bladder Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT02039310

HUM00057382

Details and patient eligibility

About

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.

Enrollment: 59 patients

Sex: All

Ages: 65+ years old

Volunteers: No 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

Trial design

59 participants in 1 patient group

≥ 65 years / opts for radical cystectomy