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

Bladder Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02039310
• Other study ID #: HUM00057382
• Status: Completed
• Phase: N/A
• First received: January 15, 2014
• Last updated: July 25, 2017
• Start date: March 2012
• Est. completion date: December 31, 2015

Study information

• Verified date: July 2017
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: December 31, 2015
• Est. primary completion date: December 31, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bladder Cancer
• Urinary Bladder Neoplasms

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Impairment Free Survival	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.	6 months