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

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

INTRODUCTION

  • Org Study ID: LCCC1206
  • Secondary ID: 12-0577
  • NTC ID: NCT01776138
  • 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.

  • Overall Status
    Active, not recruiting
  • Start Date
    April 2012
  • Phase
  • Study Type
    Observational

PRIMARY OUTCOMES

Primary Outcome 1 - 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

Primary Outcome 1 - Timeframe: 1 Year

CONDITION

  • Bladder Cancer

ELIGIBILITY

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.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Angela Smith, MD

Role: Principal Investigator

Affiliation: University of North Carolina Lineberger Comprehensive Cancer Center

Overall Contact

Name: Angela Smith, MD

Phone: N/A

Email: N/A

LOCATION

Facility Status Contact