Study of Outcomes After Surgery/Treatment to Treat Bladder Cancer

Completed

• Conditions: Bladder Cancer
• Interventions: Other: Collect Blood and Survey Instruments

• Registration Number: NCT01776138
• Lead Sponsor: UNC Lineberger Comprehensive Cancer Center

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.

Study Timeline

• Study Start: 2012-07-23
• Study First Submitted: 2012-09-20
• Study First Submitted QC: 2013-01-22
• Study First Posted: 2013-01-25
• Primary Completion: 2019-08-29
• Study Completion: 2021-09-02
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-05
• Last Update Posted: 2021-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 103

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Bladder Cancer Patients	Collect Blood and Survey Instruments	Patients diagnoses with bladder cancer who are eligible to undergo treatment.

Primary Outcome Measures

Name	Time	Method
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	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").

Secondary Outcome Measures

Name	Time	Method
To measure associations between baseline measures with post-surgery and 90 day outcome measures	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.	2 years

Trial Locations

Locations (1)

UNC Lineberger Comprehensive Cancer Center; 🇺🇸 Chapel Hill, North Carolina, United States