Clinical trial NCT01776138: Study of Outcomes After Surgery/Treatment to Treat Bladder Cancer
Official title: PORCH: A Registry of Prospective Outcomes of Radical Cystectomy With or Without Chemotherapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bladder Cancer
Keywords: Elderly
Chemotherapy
Cystectomy
Radical Cystectomy
University of North Carolina
Cancer
Bladder Cancer
Bladder
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2013-01-25
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief 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.

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.

Primary outcomes:
measure: 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
timeFrame: 1 Year
Secondary outcomes:
measure: To measure associations between baseline measures with post-surgery and 90 day outcome measures
timeFrame: 2 years
measure: To count changes over the course of treatment for components of the GA, the FACT-Bl, p16, and other clinical characteristics.
timeFrame: 2 years
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: UNC Lineberger Comprehensive Cancer Center
state: North Carolina
Study officials:
affiliation: University of North Carolina Lineberger Comprehensive Cancer Center
name: Angela Smith, MD
role: PRINCIPAL_INVESTIGATOR
References: