Clinical trial NCT02039310: Prediction of Impaired Survival in Elderly Bladder Cancer Patients Opting for Radical Cystectomy
Official title: Prediction of Impaired Survival in Elderly Bladder Cancer Patients Opting for Radical Cystectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bladder Cancer
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2014-01-17
Enrollment: 59
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients meeting eligibility criteria will be recruited from genitourinary cancer clinics at the University of Michigan Comprehensive Cancer Center. Patients undergoing initial consultation, active treatment, or surveillance after endoscopic or intravesical therapy will be identified and screened. Interested patients will be counseled by Dr. Lee or her designee, who will review the rationale and benefits of the study, the potential risks and probability of their occurrence, and the procedures to minimize these risks. Patients who wish to enter the study will be asked to sign a consent form that meets the requirements of the University of Michigan IRB. A signed copy of the patient consent will be entered into the medical record.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Impairment Free Survival
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Cheryl T Lee, MD
role: PRINCIPAL_INVESTIGATOR
References: