PORCH: Study of Outcomes After Surgery/Treatment to Treat Bladder Cancer

Sponsor

UNC Lineberger Comprehensive Cancer Center (Other)

Overall Status

Completed

CT.gov ID

NCT01776138

Collaborator

(none)

103

Enrollment

Location

109.3

Actual Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Bladder Cancer	Other: Collect Blood and Survey Instruments

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 Design

Study Type:

Observational

Actual Enrollment :

103 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jul 23, 2012

Actual Primary Completion Date :

Aug 29, 2019

Actual Study Completion Date :

Sep 2, 2021

Arms and Interventions

Arm	Intervention/Treatment
Bladder Cancer Patients Patients diagnoses with bladder cancer who are eligible to undergo treatment.	Other: Collect Blood and Survey Instruments Other Names: p16 Blood Collection Geriatric Assessment Fact-BL Health Behavior Questionnaire

Arm

Intervention/Treatment

Bladder Cancer Patients

Patients diagnoses with bladder cancer who are eligible to undergo treatment.

Other: Collect Blood and Survey Instruments

Other Names:

p16 Blood Collection

Geriatric Assessment

Fact-BL

Health Behavior Questionnaire

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.