Study of Outcomes After Surgery/Treatment to Treat Bladder Cancer (PORCH)
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.
|Study Design:||Time Perspective: Prospective|
|Official Title:||PORCH: A Registry of Prospective Outcomes of Radical Cystectomy With or Without Chemotherapy|
- 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 [ Time Frame: 1 Year ] [ Designated as safety issue: No ]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").
- To measure associations between baseline measures with post-surgery and 90 day outcome measures [ Time Frame: 2 years ] [ Designated as safety issue: No ]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.
- To count changes over the course of treatment for components of the GA, the FACT-Bl, p16, and other clinical characteristics. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
Whole blood samples
|Study Start Date:||April 2012|
|Estimated Study Completion Date:||April 2017|
|Estimated Primary Completion Date:||April 2016 (Final data collection date for primary outcome measure)|
Bladder Cancer Patients
Patients diagnoses with bladder cancer who are eligible to undergo treatment.
Other: Collect Blood and Survey Instruments
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01776138
|Contact: Shani M Alston, MPHfirstname.lastname@example.org|
|United States, North Carolina|
|UNC Lineberger Comprehensive Cancer Center||Recruiting|
|Chapell Hill, North Carolina, United States, 27514|
|Contact: Shani Alston, MPH 919-843-1906 email@example.com|
|Principal Investigator: Angela Smith, MD|
|Sub-Investigator: Hyman Muss, MD|
|Principal Investigator:||Angela Smith, MD||University of North Carolina Lineberger Comprehensive Cancer Center|