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

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ClinicalTrials.gov Identifier: NCT01776138
Recruitment Status : Recruiting
First Posted : January 25, 2013
Last Update Posted : October 27, 2017
Sponsor:
Information provided by (Responsible Party):

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
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
Estimated Enrollment : 150 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: PORCH: A Registry of Prospective Outcomes of Radical Cystectomy With or Without Chemotherapy
Study Start Date : April 2012
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer
U.S. FDA Resources

Groups and Cohorts

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


Outcome Measures

Primary Outcome Measures :
  1. 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 [ Time Frame: 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 :
  1. To measure associations between baseline measures with post-surgery and 90 day outcome measures [ Time Frame: 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.

  2. To count changes over the course of treatment for components of the GA, the FACT-Bl, p16, and other clinical characteristics. [ Time Frame: 2 years ]

Biospecimen Retention:   Samples With DNA
Whole blood samples

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01776138


Contacts
Contact: Angie Smith, MD (919) 966-8217 angela_smith@med.unc.edu

Locations
United States, North Carolina
UNC Lineberger Comprehensive Cancer Center Recruiting
Chapel Hill, North Carolina, United States, 27514
Contact: Amy Garrett, MA    919-966-0695    amy_garrett@med.unc.edu   
Principal Investigator: Angela Smith, MD         
Sub-Investigator: Hyman Muss, MD         
Sponsors and Collaborators
UNC Lineberger Comprehensive Cancer Center
Investigators
Principal Investigator: Angela Smith, MD University of North Carolina Lineberger Comprehensive Cancer Center
More Information

Responsible Party: UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01776138     History of Changes
Other Study ID Numbers: LCCC1206
12-0577 ( Other Identifier: UNC IRB )
First Posted: January 25, 2013    Key Record Dates
Last Update Posted: October 27, 2017
Last Verified: October 2017

Keywords provided by UNC Lineberger Comprehensive Cancer Center:
Elderly
Chemotherapy
Cystectomy
Radical Cystectomy
University of North Carolina
Cancer
Bladder Cancer
Bladder

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases