Study of Outcomes After Surgery/Treatment to Treat Bladder Cancer (PORCH)
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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 |
- 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 ] [ Designated as safety issue: No ]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").
- To measure associations between baseline measures with post-surgery and 90 day outcome measures [ Time Frame: 2 years ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
Whole blood samples
| Estimated Enrollment: | 25 |
| Study Start Date: | April 2012 |
| Estimated Study Completion Date: | April 2015 |
| Estimated Primary Completion Date: | April 2013 (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:
|
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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.
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| Contact: Shani M Alston, MPH | 919-843-1906 | shani_alston@med.unc.edu |
| 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 | |
| Principal Investigator: | Angela Smith, MD | University of North Carolina Lineberger Comprehensive Cancer Center |
More Information
No publications provided
| Responsible Party: | UNC Lineberger Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT01776138 History of Changes |
| Other Study ID Numbers: | LCCC1206, 12-0577 |
| Study First Received: | September 20, 2012 |
| Last Updated: | January 30, 2013 |
| Health Authority: | United States: Institutional Review Board |
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 |
ClinicalTrials.gov processed this record on May 22, 2013