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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


  • Org Study ID: LCCC1206
  • Secondary ID: 12-0577
  • NCT ID: NCT01776138
  • NCT Alias:
  • Sponsor: UNC Lineberger Comprehensive Cancer Center - Other
  • Source: 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.

Overal Status Start Date Phase Study Type
Recruiting Start Date: April 2012 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 - Time Frame: 1 Year

Condition:

  • Bladder Cancer

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.
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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: Angie Smith, MD

Phone: (919) 966-8217

Email: angela_smith@med.unc.edu

Location

Facility Status Contact
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina 27514
United States
Recruiting Amy Garrett, MA
919-966-0695
amy_garrett@med.unc.edu