Study of Outcomes After Surgery/Treatment to Treat Bladder Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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PORCH: A Registry of Prospective Outcomes of Radical Cystectomy With or Without Chemotherapy

Conditions
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Bladder Cancer

Intervention / Treatment
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* Other: Collect Blood and Survey Instruments


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Bladder Cancer Patients<br>Patients diagnoses with bladder cancer who are eligible to undergo treatment. | Other: Collect Blood and Survey Instruments<br> <br> * Other names: Health Behavior Questionnaire;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To collect the number of changes in functional status, surgical complications and survival status collected in a prospective database of patients undergoing a radical cystectomy with or without chemotherapy | To collect the number of changes in functional status, surgical complications, and survival in patients with urothelial carcinoma of the bladder following radical cystectomy with or without neoadjuvant chemotherapy in a prospective database (to be called the PORCH database- Prospective Outcomes of Radical cystectomy with or without Chemotherapy). | 1 Year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To measure associations between baseline measures with post-surgery and 90 day outcome measures | Measure the association of all baseline measures with the outcomes of complications post-surgery and 90 day mortality for the 25 patients entered into the database who complete the GA and FACT-Bl questionnaires. | 2 years | 
| To count changes over the course of treatment for components of the GA, the FACT-Bl, p16, and other clinical characteristics. |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Elderly, Chemotherapy, Cystectomy, Radical Cystectomy, University of North Carolina, Cancer, Bladder Cancer, Bladder