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

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

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.

Study Overview

• Status: Completed
• Conditions: Bladder Cancer
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 103

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27514
      • UNC Lineberger Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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").	1 Year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To measure associations between baseline measures with post-surgery and 90 day outcome measures	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.	2 years
To count changes over the course of treatment for components of the GA, the FACT-Bl, p16, and other clinical characteristics.		2 years

Collaborators and Investigators

• Sponsor: UNC Lineberger Comprehensive Cancer Center
• Investigators: Principal Investigator: Angela Smith, MD, University of North Carolina Lineberger Comprehensive Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): July 23, 2012
• Primary Completion (Actual): August 29, 2019
• Study Completion (Actual): September 2, 2021

Study Registration Dates

• First Submitted: September 20, 2012
• First Submitted That Met QC Criteria: January 22, 2013
• First Posted (Estimate): January 25, 2013

Study Record Updates

• Last Update Posted (Actual): October 6, 2021
• Last Update Submitted That Met QC Criteria: October 5, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Elderly; Cancer; Radical Cystectomy; Cystectomy; Chemotherapy; Bladder; Bladder Cancer; University of North Carolina
• Additional Relevant MeSH Terms: Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Urologic Diseases; Urinary Bladder Diseases; Urinary Bladder Neoplasms
• Other Study ID Numbers: LCCC1206; 12-0577 (Other Identifier: UNC IRB)