This pilot clinical trial studies the impact of radical cystectomy (surgery) on the expulsion (release) of circulating tumor cells into the blood stream in patients with bladder cancer. Significant surgery such as radical cystectomy may cause the expulsion of tumor cells. Studying the release of tumor cells into the circulation may help doctors understand the impact that radical cystectomy has on tumor metastasis and/or tumor recurrence.
PRIMARY OBJECTIVES: I. To detect the numbers of circulating tumor cells (CTCs) during and following radical cystectomy in both the peripheral and central line. SECONDARY OBJECTIVES: I. To ensure the safety and of using the femoral vein to access the central venous blood supply for patients with primary bladder cancer and the withdrawal of blood from both a peripheral and central line. OUTLINE: Patients undergo placement of a central line via the right femoral vein and undergo open radical cystectomy (ORC). Blood samples are collected and analyzed for CTCs pre-surgery, at 30 minutes and 1 hour once ORC begins, post-surgery, and 7 days after surgery. After completion of study, patients are followed up at 2 weeks and at 1 month.
Study Type
OBSERVATIONAL
Insertion of venous catheter under ultrasound guidance
Collection of blood samples
Correlative studies
Number of CTCs in the blood drawn from central line
Will estimate the mean and standard deviation (possibly after log transformation to render data compatible with the assumptions of the normal distribution) at each time point (during and after radical cystectomy) as well as the changes over time.
Time frame: Up to post-operative day 7
Number of CTCs in the blood drawn from peripheral line
Will estimate the mean and standard deviation (possibly after log transformation to render data compatible with the assumptions of the normal distribution) at each time point (during and after radical cystectomy) as well as the changes over time.
Time frame: Up to post-operative day 7
Incidence of complications during the cannulation of the femoral vein
All complications will be recorded that occur during the insertion of femoral line, at any time during the surgical procedure or within 30 days of discharge from the hospital
Time frame: Up to 1 month from discharge
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