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


N/A
18 Years
N/A
Open (Enrolling)
Both
Bladder Cancer

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Trial Information

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


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.


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.

Type of Study:

Observational

Study Design:

Time Perspective: Prospective

Outcome 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

Outcome Description:

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").

Outcome Time Frame:

1 Year

Safety Issue:

No

Principal Investigator

Angela Smith, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of North Carolina Lineberger Comprehensive Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

LCCC1206

NCT ID:

NCT01776138

Start Date:

April 2012

Completion Date:

April 2015

Related Keywords:

  • Bladder Cancer
  • Elderly
  • Chemotherapy
  • Cystectomy
  • Radical Cystectomy
  • University of North Carolina
  • Cancer
  • Bladder Cancer
  • Bladder
  • Urinary Bladder Neoplasms

Name

Location
UNC Lineberger Comprehensive Cancer Center Chapel Hill, North Carolina