Have you or your loved ones been diagnosed with bladder cancer?

You may be eligible to participate in a bladder cancer clinical trial.

Have you or your loved ones been diagnosed with bladder cancer? You may be eligible to participate in a bladder cancer clinical trial.

What is a clinical trial? Is participating in a clinical trial right for you? Learn more

Bladder Cancer Clinical Trial in Chapel Hill NC

NCT01776138 | Observational

Have you or your loved ones been diagnosed with bladder cancer?

You may be eligible to participate in a bladder cancer clinical trial.

Have you or your loved ones been diagnosed with bladder cancer? You may be eligible to participate in a bladder cancer clinical trial.

Completed

Male & Female

18 Years +

This study has recruited 103 Participants

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.

Show me more details

Details for the 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.

Brief Title

Study of Outcomes After Surgery/Treatment to Treat Bladder Cancer

Official Title

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

Brief Summary

The purpose of this study is to create a registry of older patients undergoing surgical <br /> and/or medical treatment for bladder cancer. The registry will record side-effect and <br /> outcomes related to the treatment using different surveys and biological measures.

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.

Outcome Measures

Outcome measures are the tests that investigators perform to prove whether or not a treatment being tested in a clinical trial is having any effect.

Primary

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

Secondary

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

Study 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.