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

Sponsor
University of Michigan (Other)
Overall Status
Completed
CT.gov ID
NCT02039310
Collaborator
(none)
59
Enrollment
1
Location
46
Duration (Months)
1.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    59 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Prediction of Impaired Survival in Elderly Bladder Cancer Patients Opting for Radical Cystectomy
    Study Start Date :
    Mar 1, 2012
    Actual Primary Completion Date :
    Dec 31, 2015
    Actual Study Completion Date :
    Dec 31, 2015

    Arms and Interventions

    Arm Intervention/Treatment
    ≥ 65 years / opts for radical cystectomy

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    65 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Michigan Ann Arbor Michigan United States 48109

    Sponsors and Collaborators

    • University of Michigan

    Investigators

    • Principal Investigator: Cheryl T Lee, MD, University of Michigan

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Cheryl Lee, PI, University of Michigan
    ClinicalTrials.gov Identifier:
    NCT02039310
    Other Study ID Numbers:
    • HUM00057382
    First Posted:
    Jan 17, 2014
    Last Update Posted:
    Jul 27, 2017
    Last Verified:
    Jul 1, 2017
    Additional relevant MeSH terms:
    Urinary Bladder Neoplasms

    Study Results

    No Results Posted as of Jul 27, 2017