Study of Outcomes After Surgery/Treatment to Treat Bladder Cancer
Conditions
Bladder Cancer
Conditions: official terms
Urinary Bladder Neoplasms
Conditions: Keywords
Elderly, Chemotherapy, Cystectomy, Radical Cystectomy, University of North Carolina, Cancer, Bladder Cancer, Bladder
Study Type
Observational
Study Phase
N/A
Study Design
Time Perspective: Prospective
Intervention
Name: Collect Blood and Survey Instruments
Type: Other
Overall Status
Recruiting
Summary
The purpose of this study is to create a registry of older patients undergoing surgical and/or medical treatment for bladder cancer. The registry will record side-effect and outcomes related to the treatment using different surveys and biological measures.
Detailed Description
The primary purpose of this protocol is to create a registry of elderly patients with high-risk invasive bladder cancer undergoing radical cystectomy with or without preoperative chemotherapy.

Secondary objectives will include an exploration of the association between functional status, surgical complications, and laboratory markers with complications and survival. In addition, exploratory analyses may evaluate the association of expression of the senescence marker p16INK4a and the morbidity and mortality associated with treatment.

Patients will be asked to complete a Geriatric Assessment (GA) and FACT-Bl serially over the course of the study in order to evaluate their functional status and quality of life during the course of treatment. Additionally, complications will be tracked in an inpatient and outpatient setting using the Memorial Sloan Kettering Cancer Center (MSKCC) complications grading system.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- Patients with a known pathologic diagnosis of lower tract urothelial carcinoma who are eligible to undergo radical cystectomy with or without neoadjuvant chemotherapy for definitive diagnosis and treatment.

- Signed, IRB approved written informed consent.

- Completion of baseline Geriatric Assessment

Exclusion Criteria:

- Inability to read and speak English

- Inability to comply with study for any other reason than language

- Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent.
Location
UNC Lineberger Comprehensive Cancer Center
Chapell Hill, North Carolina, United States
Status: Recruiting
Contact: Shani Alston, MPH - 919-843-1906 - shani_alston@med.unc.edu
Start Date
April 2012
Completion Date
April 2017
Sponsors
UNC Lineberger Comprehensive Cancer Center
Source
UNC Lineberger Comprehensive Cancer Center
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page