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

NCT02039310 | Completed

• 1 other identifier: HUM00057382
• Study Type: observational
• Target: 59
• Locations: 1 country
• Sites: 1

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.

Conditions

Bladder Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

≥ 65 years / opts for radical cystectomy

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

urine, serum, psoas muscle specimen

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Cheryl T Lee, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: January 15, 2014
• First Posted: January 17, 2014
• Study Start: March 1, 2012
• Primary Completion: December 31, 2015
• Study Completion: December 31, 2015
• Last Updated: July 27, 2017

Record last verified: 2017-07

Locations

US (1)