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NCT02039310 · ClinicalTrials.gov registry record

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

A clinical trial, sponsored by University of Michigan.

Completed
Registry status
59
Enrollment target

NCT02039310: Completed study, sponsored by University of Michigan.

NCT02039310 is a clinical trial that has completed, run by University of Michigan. The registered enrollment target is 59 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02039310 has completed, sponsored by University of Michigan.

COMPLETED
Registry status
59 participants
Enrollment target

Study 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.

Primary Outcome

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.

Trial Details

FieldValue
Enrollment Target 59 participants
Start Date 2012-03
Est. Completion 2015-12-31
University of Michigan

1,327 total trials

What the finished NCT02039310 record still lists

NCT02039310 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 59 participants, a relatively small participant target.

The record links to 0 conditions, and to 0 interventions.

NCT02039310 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02039310 about?

NCT02039310 is a clinical study titled "Prediction of Impaired Survival in Elderly Bladder Cancer Patients Opting for Radical Cystectomy". 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. I...

What is the current status of trial NCT02039310?

This trial is currently completed. The enrollment target is 59 participants. The study started on 2012-03. Estimated completion is 2015-12-31.

Who is sponsoring clinical trial NCT02039310?

This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT02039310, the US trial registry maintained by the National Library of Medicine. NCT02039310 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.