Study of Outcomes After Surgery/Treatment to Treat Bladder Cancer (PORCH)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01776138|
Recruitment Status : Recruiting
First Posted : January 25, 2013
Last Update Posted : November 30, 2018
|Condition or disease||Intervention/treatment|
|Bladder Cancer||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.
|Study Type :||Observational|
|Estimated Enrollment :||150 participants|
|Official Title:||PORCH: A Registry of Prospective Outcomes of Radical Cystectomy With or Without Chemotherapy|
|Study Start Date :||April 2012|
|Estimated Primary Completion Date :||April 2020|
|Estimated Study Completion Date :||April 2021|
Bladder Cancer Patients
Patients diagnoses with bladder cancer who are eligible to undergo treatment.
Other: Collect Blood and Survey Instruments
- 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 ]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 ]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 ]
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01776138
|Contact: Angie Smith, MD||(919) email@example.com|
|United States, North Carolina|
|UNC Lineberger Comprehensive Cancer Center||Recruiting|
|Chapel Hill, North Carolina, United States, 27514|
|Contact: Amy Garrett, MA 919-966-0695 firstname.lastname@example.org|
|Principal Investigator: Angela Smith, MD|
|Sub-Investigator: Hyman Muss, MD|
|Principal Investigator:||Angela Smith, MD||University of North Carolina Lineberger Comprehensive Cancer Center|