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| ID | Type | Description | Link |
|---|---|---|---|
| 12-0577 | Other Identifier | UNC IRB |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bladder Cancer Patients | Patients diagnoses with bladder cancer who are eligible to undergo treatment. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Collect Blood and Survey Instruments | Other |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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"). | 1 Year |
| Measure | Description | Time Frame |
|---|---|---|
| To measure associations between baseline measures with post-surgery and 90 day outcome measures | 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 years |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Angela Smith, MD | University of North Carolina Lineberger Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UNC Lineberger Comprehensive Cancer Center | Chapel Hill | North Carolina | 27514 | United States |
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| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| D015577 | Geriatric Assessment |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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Whole blood samples
| To count changes over the course of treatment for components of the GA, the FACT-Bl, p16, and other clinical characteristics. |
| 2 years |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D006304 | Health Status |
| D003710 | Demography |
| D011154 | Population Characteristics |
| D015991 | Epidemiologic Measurements |