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

This study is currently recruiting participants.
Verified July 2016 by UNC Lineberger Comprehensive Cancer Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT01776138
First Posted: January 25, 2013
Last Update Posted: July 19, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
UNC Lineberger Comprehensive Cancer Center
  Purpose
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 Intervention
Bladder Cancer Other: Collect Blood and Survey Instruments

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: PORCH: A Registry of Prospective Outcomes of Radical Cystectomy With or Without Chemotherapy

Resource links provided by NLM:


Further study details as provided by UNC Lineberger Comprehensive Cancer Center:

Primary Outcome Measures:
  • 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:
  • 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.

  • 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

Estimated Enrollment: 150
Study Start Date: April 2012
Estimated Study Completion Date: April 2021
Estimated Primary Completion Date: April 2020 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Information from the National Library of Medicine

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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: Shani M Alston, MPH 919-843-1906 shani_alston@med.unc.edu

Locations
United States, North Carolina
UNC Lineberger Comprehensive Cancer Center Recruiting
Chapell Hill, North Carolina, United States, 27514
Contact: Shani Alston, MPH    919-843-1906    shani_alston@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 Submitted: September 20, 2012
First Posted: January 25, 2013
Last Update Posted: July 19, 2016
Last Verified: July 2016

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