Bladder Cancer Clinical Trial
Study of Outcomes After Surgery/Treatment to Treat Bladder Cancer
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.
Full 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.
Eligibility 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.
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There is 1 Location for this study
Chapel Hill North Carolina, 27514, United States
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