NCT01776138

Study of Outcomes After Surgery/Treatment to Treat Bladder Cancer

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 103 (actual)
• Sponsor: UNC Lineberger Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Bladder Cancer

Interventions

Type	Name	Description
OTHER	Collect Blood and Survey Instruments

Timeline

• Start date: 2012-07-23
• Primary completion: 2019-08-29
• Completion: 2021-09-02
• First posted: 2013-01-25
• Last updated: 2021-10-06

Locations

1 site across 1 country: United States